Brachytherapy apparatus and methods for using them

ABSTRACT

Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways.

This application is a continuation of co-pending application Ser. No.11/276,851, filed Mar. 16, 2006, and issuing as U.S. Pat. No. 7,862,496,which claims benefit of U.S. Provisional Application Ser. No.60/735,649, filed Nov. 10, 2005, the entire disclosures of which areexpressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus, methods, andsystems for providing brachytherapy to a human or other mammalian body,and more particularly to expandable apparatus for performingbrachytherapy treatment within tissue, e.g., within breast tissue and/orwithin a body cavity, and to methods for performing brachytherapy usingsuch apparatus.

BACKGROUND

Brachytherapy is a type of radiation therapy used to treat malignanttumors, such as cancer of the breast or prostate. In general,brachytherapy involves positioning a radiation source directly intotarget tissue, which may include a tumor and/or tissue surrounding acavity or void, which may contain potentially cancerous cells (such as acavity or void created by removing a tumor).

Brachytherapy is often divided into two categories: high dose rate (HDR)and low dose rate (LDR) brachytherapy. In HDR brachytherapy, a highactivity radiation source is placed into target tissue, often via apreviously implanted catheter, for a short period of time, e.g., lastingfrom several seconds to a few minutes. In contrast, LDR brachytherapyplaces a low activity radiation source into the target tissue for alonger, sometimes indefinite, period of time.

Both forms of brachytherapy have advantages. For instance, HDRbrachytherapy provides higher radiation levels delivered over a shorterdose delivery period. LDR brachytherapy, on the other hand, utilizeslower activity radiation sources. The energy field of the LDR radiationsource results in a measured and localized dose of radiation deliveredto target tissue, e.g., a tumor, gland, or other tissue surrounding acavity or void. However, the energy field thereafter decays to avoidexcessive exposure of nearby healthy tissue.

Due in part to the lower activity of LDR radiation sources, LDRbrachytherapy may provide various advantages. For example, forhealthcare workers, exposure precautions for LDR brachytherapy may beless stringent than those for HDR brachytherapy. Also there areradiobiological advantages of LDR brachytherapy over HDR brachytherapy(e.g. the dose rate effect), which can lead to better sparing of normaltissue during treatment. Moreover, for patients, the relatively longerimplantation period associated with LDR brachytherapy may result infewer visits to a healthcare facility over the course of radiationtreatment, as compared to HDR brachytherapy where patients must returnto the healthcare facility for each fraction of radiation delivered,which, for breast brachytherapy, may typically include eight to ten(8-10) fractions.

Common radiation sources used in LDR brachytherapy include radioactiveisotopes such as Palladium (Pd)-103, Iodine (I)-125, Gold (Au)-198, andIridium (Ir)-192. While the size and shape of the isotopes may vary,they are provided, in common applications (e.g., prostatebrachytherapy), in a standardized size of cylindrically shaped capsulesthat are approximately the size of a grain of rice, e.g., about 0.8millimeter in diameter and about 4.5 millimeters in length, and areoften referred to as “seeds.”

LDR seeds are often delivered through needles using a guide template.The guide template may include a matrix of holes that guide thelongitudinal advancement of the needles to ensure their proper positionrelative to the target tissue. Once the needles are properly located inthe target tissue, the seeds may be deposited along the longitudinalaxis of each needle, after which the needles may be withdrawn.

While effective, current brachytherapy implementations have potentialdrawbacks. For example, the LDR seeds are typically left indwelling andfree floating within the target tissue and are, therefore, susceptibleto migration. Moreover, once implanted, LDR seeds are generally notconsidered removable or repositionable. LDR brachytherapy may alsorequire careful dose distribution calculations and seed mapping before,and often during, seed implantation. Such calculation and mapping mayallow effective radiation delivery to the target tissue volume, whileminimizing radiation to surrounding healthy tissue (e.g., the urethraand rectum, for example, in prostate brachytherapy). Yet, while suchdose calculation and seed mapping techniques are effective, problems mayexist, such as potentially significant variability in accuracy of seedplacement among different clinicians.

Yet another issue with conventional LDR brachytherapy techniques is thatmany of these techniques often require the radioactive seeds to bemanipulated individually at the time of implantation, an oftentime-consuming process. Moreover, conventional LDR delivery needles aregenerally limited to delivering the seeds linearly (along a relativelystraight line). Thus, to achieve a desired therapy profile, numerousimplants (e.g., including about 50-100 seeds, as are common withprostate brachytherapy) are often required, in conjunction withpotentially complex dose distribution and mapping techniques andequipment.

SUMMARY

The present invention is generally directed to apparatus and methods fordelivering brachytherapy to a localized target tissue region. While theinvention is useful in treating most any area of the body, it offersparticular advantages in the treatment of breast tissue, e.g., breasttumors or lumpectomy cavities. For example, the invention may be used toplace and remove a localized radiation source for both neoadjuvant andpost-excisional treatment.

Exemplary embodiments of the invention are directed to brachytherapydevices and apparatus. Such devices and apparatus are capable ofdelivering brachytherapy treatment to a target region (e.g., breasttissue region). Other embodiments are directed to deliveringbrachytherapy devices to the target region. Systems and methods fordelivering brachytherapy to the target region are also provided.

In accordance with one embodiment, a brachytherapy treatment apparatusis provided that includes an elongate body including a proximal end anda distal end sized for introduction into a tract through tissue. Aplurality of elongate members may be provided on the distal endincluding pathways for receiving a source of radiation therealong, theelongate members being movable from a collapsed configuration forintroduction through a tissue tract to a target location, and anexpanded configuration. A source of radiation may be introduceable alongthe pathways for delivering radiation to the target location.

In accordance with another embodiment, a method is provided forbrachytherapy treatment of tissue within a body that includes creating atract through tissue to a target location comprising a cavity, andadvancing an elongate body carrying a plurality of elongate membersthrough the tract into the target location with the elongate members ina collapsed configuration. The elongate members may be directed to anexpanded configuration at the target location to position the elongatemembers away from a central axis such that tissue in the target region(e.g., surrounding the cavity) extends between at least a portion ofadjacent elongate members, and radiation may be delivered to the targetlocation to treat tissue at the target location.

The above summary is not intended to describe each embodiment or everyimplementation of the present invention. Rather, a more completeunderstanding of the invention will become apparent and appreciated byreference to the following detailed description and claims in view ofthe accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further described with reference to thedrawing, wherein:

FIG. 1 illustrates an exemplary brachytherapy apparatus or kit inaccordance with one embodiment;

FIGS. 2A-2E are diagrammatic illustrations of a method for using thebrachytherapy apparatus of FIG. 1;

FIG. 2F is a diagrammatic illustration of another brachytherapyapparatus in accordance with another embodiment;

FIGS. 3A-3B are enlarged partial views of a brachytherapy device inaccordance with yet another embodiment;

FIGS. 4A-4B are enlarged partial views of a brachytherapy device inaccordance with still another embodiment;

FIGS. 5A-5B are enlarged partial views of a brachytherapy device inaccordance with yet another embodiment;

FIG. 5C is a view of the brachytherapy device of FIGS. 5A-5Billustrating an exemplary removal method;

FIG. 6 is an exploded view of a brachytherapy apparatus or kit inaccordance with yet another embodiment;

FIG. 7 illustrates the brachytherapy apparatus of FIG. 6 as it may bepartially assembled;

FIGS. 8A-8E are diagrammatic illustrations of a method of using thebrachytherapy apparatus of FIGS. 6 and 7;

FIGS. 9A-9B are enlarged partial views of a brachytherapy device inaccordance with another embodiment;

FIGS. 10A-10B are enlarged partial views of a brachytherapy device inaccordance with yet another embodiment;

FIGS. 11A-11B are enlarged partial views of a brachytherapy device inaccordance with still another embodiment;

FIGS. 12A-12B are enlarged partial views of a brachytherapy device inaccordance with still another embodiment;

FIGS. 13A-13B are enlarged partial views of a brachytherapy device inaccordance with yet another embodiment;

FIGS. 14A-14B are enlarged partial views of a brachytherapy device inaccordance with still another embodiment;

FIG. 15 is a diagrammatic view of a brachytherapy apparatus inaccordance with another embodiment;

FIGS. 16A-16G are diagrammatic illustrations of non-linear brachytherapyapparatus and methods in accordance with various embodiments, wherein:FIGS. 16A-16E illustrate a dual, off-axis catheter assembly; and FIGS.16F-16G illustrate a spiral-shaped catheter;

FIGS. 17A-17B illustrate a brachytherapy apparatus in accordance withyet another embodiment;

FIG. 18 is a view of a radiation attenuating garment, e.g., brassiere,in accordance with one embodiment;

FIGS. 19A-19C are diagrammatic views of a balloon catheter assembly,e.g., HDR catheter, in accordance with one embodiment;

FIG. 20 is an exemplary embodiment of a deliver or implantation systemfor use with the brachytherapy methods and apparatus described herein;

FIG. 21 is a diagrammatic view of the delivery system FIG. 20 as it maybe used with the brachytherapy methods and apparatus described herein,e.g., the methods described in FIGS. 2A-2F and 8A-8E;

FIG. 22 is an enlarged view of an exemplary catheter, e.g., needle,guiding template for use with the delivery system of FIG. 21;

FIG. 23 is a diagrammatic view of another delivery or implantationsystem for use with the brachytherapy methods and apparatus describedherein;

FIG. 24 is an exploded view of a portion, e.g., a cartridge, of thedelivery system of FIG. 23;

FIGS. 25A-25D are diagrammatic illustrations of a delivery orimplantation system and method in accordance with yet anotherembodiment;

FIG. 26 is a view of a portion of a human body, e.g., a female breast,after the brachytherapy devices as described herein have been implantedand secured;

FIG. 27 is a cross-section of a portion of the delivery system of FIGS.25A-25D;

FIGS. 28A-28D illustrate an intracavitary brachytherapy treatmentapparatus, wherein: FIG. 28A illustrates the apparatus in a collapsed,e.g., linear, configuration; FIGS. 28B and 28C illustrate the apparatusin partially expanded or deployed configurations; and FIG. 28Dillustrates the apparatus in a fully deployed configuration;

FIGS. 29A-29F illustrate an intracavitary brachytherapy treatmentapparatus, wherein: FIG. 29A is a perspective view of the apparatus inan expanded or deployed, e.g., curvilinear, configuration; FIG. 29B is asection view of the apparatus in a collapsed, e.g., straight,configuration and positioned within a lumpectomy cavity; FIG. 29C is asection view of the apparatus in the partially deployed configurationwithin the cavity; FIG. 29D is a cross-section taken along lines 29D-29Dof FIG. 29C; FIG. 29E illustrates an alternative partial cross-sectionof a portion of the apparatus of FIG. 29D; and FIG. 29F illustrates aperspective view of a portion of the apparatus;

FIGS. 30A-30C illustrate an intracavitary brachytherapy treatmentapparatus in accordance with yet another embodiment, wherein: FIG. 30Ais a side elevation view in an expanded or deployed, e.g., curvilinear,configuration; FIG. 30B is a section view of the apparatus in acollapsed, e.g., straight configuration; and FIG. 30C is a section viewof the apparatus in the expanded or deployed configuration;

FIGS. 31A-31F illustrate an intracavitary or curvilinear brachytherapytreatment apparatus in accordance with still another embodiment,wherein: FIG. 31A is a perspective view of the apparatus in a collapsed,e.g., straight, configuration; FIG. 31B is a perspective view of theapparatus in an expanded or deployed, e.g., curvilinear, configuration;FIG. 31C is a side elevation view of the apparatus in the collapsedconfiguration; FIG. 31D is an end elevation view of the apparatus in thecollapsed configuration; FIG. 31E is a section view of the apparatus inthe collapsed configuration; and FIG. 31F is a section view of theapparatus in the deployed configuration;

FIGS. 32A-32G illustrate an exemplary method of using the apparatus ofFIGS. 31A-31F to delivery brachytherapy to a cavity within a body, e.g.,a lumpectomy cavity of a breast, wherein: FIG. 32A is a perspective viewof the apparatus collapsed and implanted; FIGS. 32B and 32C are frontand side elevation views of the implanted and collapsed apparatus,respectively; FIG. 32D is a perspective cross section of the breast withthe apparatus in the deployed configuration; FIG. 32E is a section viewof the breast with the apparatus in the deployed configuration; FIG. 32Fis a diagrammatic view of the apparatus deployed within the cavity; andFIG. 32G is a diagrammatic section view illustrating exemplary radiationcoverage provided by the apparatus;

FIG. 32H is a cross-sectional view of an apparatus deployed within alumpectomy cavity within a tissue structure, showing penetration ofelongate members of the apparatus into surrounding tissue.

FIGS. 33A-33G illustrate an intracavitary brachytherapy treatmentapparatus in accordance with yet another embodiment; wherein: FIG. 33Ais a side elevation view of the apparatus in a collapsed configuration;FIG. 33B is a perspective view of the apparatus in a deployedconfiguration; FIG. 33C is a side elevation view of the apparatus in thedeployed configuration; FIG. 33D is a cross section taken along line22D-22D of FIG. 33C; FIG. 33E is another section view of the apparatus;FIG. 33F illustrates the apparatus implanted and partially deployedwithin a target tissue region; and FIG. 33G illustrates the apparatusfully deployed within the target tissue region; and

FIG. 34 illustrates a brachytherapy apparatus in accordance with stillyet another embodiment, wherein the apparatus is deployed within atarget tissue region.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

In the following detailed description of exemplary embodiments,reference is made to the accompanying drawings, which form a parthereof, and in which are shown by way of illustration specificembodiments in which the invention may be practiced. It is to beunderstood that other embodiments may be utilized and structural changesmay be made without departing from the scope of the present invention.

Generally speaking, the present invention is directed to brachytherapyapparatus and methods. For example, in one embodiment, a system isprovided for delivering one or more therapeutic elements (e.g.,radiation sources) relative to a target tissue region. Once delivered,the radiation sources may be either immediately withdrawn (e.g., in HDRapplications), or left in place, e.g., implanted, for a defined period(e.g., in LDR applications). In either instance, the radiation sourcesmay deliver therapy to the target tissue region in accordance with apredefined therapy profile.

In some embodiments, LDR radiation sources may be implanted and securedto the body or target tissue in such a way as to prevent orsubstantially limit movement of the sources relative to the targettissue. Unlike conventional LDR brachytherapy, the apparatus and methodsdescribed herein may facilitate indwelling therapy using pre-arrangedpackages of radioactive sources, e.g., seeds, but also allow easyremoval of the radiation sources at the completion of brachytherapy.

As used herein, “radiation source” and “radioactive source” may includemost any therapeutic element operable to deliver a dose of radiation.For example, the radiation source may be one or more radioactive seedsor, alternatively, one or more LDR or HDR wire elements (e.g., Iridiumwire).

The term “implantable,” as used herein, indicates the capability of adevice to be inserted into the body and then maintained in a relativelyfixed or static position within the surrounding tissue, for an extendedperiod of time, e.g., an hour or more and, more preferably, severalhours or more, including several days or more.

Furthermore, “target tissue,” “target tissue region,” “target region,”and “target tissue volume,” as used herein, may include most any portionof a human (or other mammalian) body that has been identified to benefitfrom radiation therapy. For example, the target tissue region may be atumor or lesion itself, tissue proximate or surrounding the tumor, or acavity region created by tumor excision (such as the surrounding tissueor cavity associated with a lumpectomy cavity of the breast).

It should be noted that, while described herein primarily with respectto LDR brachytherapy, the apparatus and methods described herein mayalso be used for HDR brachytherapy (e.g., HDR catheters), as describedfurther below. Moreover, while described herein with respect tobrachytherapy, the apparatus and methods may apply to other therapyregimens that benefit from the removable implantation oftherapy-delivering elements.

For the sake of brevity, the apparatus and methods are described hereinfor treating breast cancer. However, this particular application is notlimiting. That is, those of skill in the art will readily appreciatethat the systems, apparatus, and methods described herein may apply tomost any cancer that may receive benefit from brachytherapy.

With this introduction, turning to the drawings, FIG. 1 illustrates anexemplary kit or apparatus 100 for providing brachytherapy to a targettissue region of a body. The apparatus 100 may include an elongate andflexible, removably implantable brachytherapy treatment device 102 (alsoreferred to hereinafter as “brachytherapy device 102”) having a therapydelivery portion 104, and an elongate and flexible tail portion 106. Thetail portion 106 may, as further described below, provide the ability toremove the device 102 at therapy completion. Other components describedbelow, e.g., locking members, may also be included with the apparatus100.

The term “flexible” is used herein to describe a component that ishighly pliant, e.g., a component that may be substantially and easilybent, flexed, and/or twisted without experiencing breakage or permanentdeformation.

The therapy delivery portion 104 may form a carrier pod of therapeuticelements, e.g., radiation sources such as radioactive seeds 108, securedrelative to one another and to the therapy delivery portion 104. One ormore spacers 110 may optionally be located between each seed 108 toobtain the desired seed separation.

The seeds 108 may be produced from most any acceptable radioactivesource now known (e.g., radioactive Palladium, Iodine, Cesium, orIridium) or later developed. Typically, numerous seeds 108 are providedand precisely placed along the length of the therapy delivery portion104 in order to correspond to the desired therapy delivery regimen. Theseeds 108 may have the same radiation intensity or one or more seeds 108in a pod may have different radiation intensities from one another. Insome applications, one or more of the seeds 108 may be separated byspacers of varying length to achieve the desired dose effect. While theradioactive sources are described herein as seeds 108, they may takeother forms such as a continuous filament (or numerous discontinuoussegments) of radioactive wire (e.g., Iridium wire).

In some embodiments, the brachytherapy device 102 may include a flexiblecasing or casing member, illustrated in the figures as tube or tubemember 112, in which the seeds 108 and optional spacers 110 are securelyretained. In some embodiments, the casing is made from a non-dissolvingand flexible, heat-shrinkable tubing material. “Heat-shrinkable tubing,”as used herein, refers to tubing, such as various plastic tubing, inwhich subsequent thermal exposure causes the tubing to shrink, therebyallowing it to securely retain the seeds 108 in place. Exemplaryheat-shrinkable materials include polyester, fluorinated polymers, andpolyolefins.

While most any number of tubing sizes is contemplated, in oneembodiment, the tube 112 may have an initial inside diameter of about 1mm and a wall thickness of about 0.05 mm. Once heated, the tube 112 mayshrink (if unconstrained) to an outer diameter ranging from about 0.3 mmto about 0.6 mm.

While the casing is described herein generally as tube-shaped, thecasing may, in other embodiments, be most any shape that is capable ofeffectively securing the individual seeds 108 relative to the casing andto one another.

Once the seeds 108 and optional spacers 110 are located within the tube112, the tube may be shrunk by exposure to heat, thus contracting thetube 112 around the seeds 108. The tail portion 106 may be formed by anintegral portion, e.g., extension, of the casing (tube 112) that extendsbeyond the seeds 108. To reduce the diameter of the tail portion 106, itmay also be thermally treated (shrunk). Other embodiments (describedbelow) may utilize a two-part brachytherapy device, e.g., a separatefilament tail portion attached to the therapy delivery portion.

Regardless of the specific configuration, the brachytherapy devices 102described herein provide not only proper spacing of the seeds 108, butalso facilitate subsequent seed identification and removal. Moreover,because the seeds are contained within the pod defined by the therapydelivery portion 104, seeds may not require individual handling, thussimplifying inventory and handling prior to, and at the time of,implantation.

The components of the device 102, including the casing (tube 112) andtail portion 106, are preferably constructed of non-dissolvingmaterials. The term “non-dissolving” is used herein to indicate most anymaterial that does not substantially deteriorate or otherwise break downduring the implantation period.

The brachytherapy apparatus 100 may also include a catheter or needle114. While illustrated as needle 114, any other type of catheter ortubular member, such as the cannulae described further below, may alsobe used without departing from the scope of the invention. The needle114 defines a lumen 115 of sufficient size to allow the therapy device102 to pass therethrough, as indicated in FIG. 1. In some embodiments,the needle 114 may further include a hub 116 at a proximal end, e.g., toassist with manipulation of the needle and/or insertion of the therapydevice 102. A distal end of the needle 114 may form a sharpened tip 117operable to pierce the body, as further described below. The needle 114may be made from most any suitable biocompatible material. For example,it may be made from metal, e.g., stainless steel, titanium, or nickeltitanium alloy. It may also include a removable outer sheath (notshown), e.g., made of plastic, such as a fluorinated polymer.

FIGS. 2A-2E illustrate an exemplary method of using the brachytherapyapparatus 100 of FIG. 1. Once a target tissue region 202 (e.g., a tumoror tumor cavity) within body 200 is accurately located, the needle 114may be inserted into the body 200, as shown by arrow 203 in FIG. 2A, toa predetermined depth. The relative location(s) of the needle 114 and/orthe target tissue region 202 may be determined by most any method, e.g.,via ultrasound, CT scan, stereotactic X-ray, and the like. The needle114 may further be aligned with the use of a needle guiding template,e.g., as described below, or by other techniques.

Next, the brachytherapy device 102 may be inserted into the lumen 115 ofthe needle 114, as shown by arrow 205 in FIG. 2B, until the therapydelivery portion 104 is located at the desired depth relative to thetarget tissue region 202 as shown in FIG. 2C. To assist in determiningthe approximate insertion depth of the therapy device 102, the tailportion 106 may include measurement demarcations 118. Other locationverification techniques, e.g., X-ray, ultrasound, etc., may also beused. Alternatively, the needle 114 may be inserted with the therapydevice 102 at least partially loaded into the lumen 115 of the needle114.

Once the therapy device 102 is located at the desired depth, the needle114 may be withdrawn from the body in the direction 207 as shown in FIG.2D, leaving the therapy delivery portion 104 of the device 102 at thedesired position within the body 200. The tail portion 106 is preferablyof sufficient length such that it extends outside of the body 200, asshown in FIG. 2E. That is, the tail portion 106 may extend externallythrough a puncture made by the needle 114. In one embodiment, the tailportion 106 may have sufficient column strength such that the tailportion 106 may be held while the needle 114 is withdrawn, therebymaintaining the therapy delivery portion 104 at the desired position.

In order to prevent migration of the therapy delivery portion 104, alocking member 120 may be crimped or otherwise attached to the tailportion 106 of the therapy delivery device 102 immediately adjacent theassociated puncture in the body 200. The locking member 120 may assistin maintaining the location of the therapy delivery portion 104 relativeto the target tissue region 202. While most any locking member may beused, one embodiment utilizes a malleable, hat- or U-shaped lock thatcan be easily and securely crimped to the tail portion with, forexample, a surgical clip applier or similar tool. An enlarged view of anexemplary locking member 120 is illustrated in FIG. 27.

For illustration purposes, only a single therapy delivery device 102 isshown in FIGS. 2A-2E. However, in practice, multiple devices may beutilized to provide adequate dosage to the target tissue region 202. Theactual number of devices 102 may vary depending on various parameterssuch as lesion size, radiation source activity levels, and proximity toother organs/vulnerable tissue (e.g., skin, chest wall). However,quantities ranging from about five (5) to about twenty five (25) devicesare contemplated in an exemplary array of therapy devices 102.

FIG. 2F illustrates a variation of the therapy device 102 of FIGS. 2A-2Ethat may offer additional benefits, especially to the treatment ofbreast cancer. In this embodiment, a therapy device 152 similar in mostrespects to the device 102 is provided. However, the device 152 mayinclude both a first tail portion extending from a first end of atherapy delivery portion 154 and a second tail portion extending from asecond end, i.e., it may include a tail portion 156 at each end of thetherapy delivery portion 154. During implantation, the needle 114 maypass completely through the body, e.g., breast 200, such that one tailportion 156 extends out the opposite side of the breast 200. In thisway, locking members 120 may be secured at two locations relative to thetarget tissue region 202, thus preventing or substantially limitingmovement of the therapy delivery portion 154 relative to the targettissue region 202.

Unlike conventional brachytherapy catheters, which may be twomillimeters (2 mm) or more in diameter, the therapy devices 102 may beabout one millimeter (1 mm) or less in diameter at the therapy deliveryportion 104 and even smaller at the tail portion 106. This constructionpermits the devices 102 to be relatively small and flexible, and thusless obtrusive to the patient. In fact, the size and flexibility of thetail portions 106 may be similar to that of a conventional suture. As aresult, securing the tail portions 106 may be accomplished in any numberof ways including, for example, folding the tail portions against thecontour of the surrounding body and fixing them such as by tying theends and/or securing the ends with adhesive, the latter represented bybandage 2600 in FIGS. 2E and 26.

FIG. 3A is an enlarged view of the therapy device 102 of FIG. 1. Asclearly illustrated in this view, the therapy device 102 may include thetherapy delivery portion 104 and the tail portion 106. As describedabove, the therapy delivery portion 104 may include one, or preferablymore, radioactive seeds 108 separated by spacers 110 and encased withinthe casing, e.g., heat-shrinkable tube 112. The tail portion 106 may beformed by the portion of the tube 112 that does not surround the seeds108. In some embodiments, the conformal properties of the tube 112 maybe sufficient to ensure proper seed spacing, thus negating the need forspacers 110. FIG. 3B illustrates a section view through a seed 108 andthe tube 112 taken along line 3B-3B of FIG. 3A.

FIGS. 4A-4B illustrate a therapy device 402 in accordance with anotherembodiment. The device 402 is similar in many respects to the device 102described above. For example, the device 402 may include a therapydelivery portion 404 and a tail portion 406 as illustrated in FIG. 4A. Acasing, e.g., heat shrinkable tube 412, may be used to encase the seeds108 and optional spacers 110 as well as to form the tail portion 406.However, unlike the embodiment of FIGS. 3A-3B, the tube 412 may includea radioabsorptive portion 414, e.g., a substance or liner, positionedalong a portion of the circumference of the therapy delivery portion 404(see FIG. 4B). The radioabsorptive portion 414 may include a radiationattenuating material, which may reduce radiation exposure to tissueblocked by the radioabsorptive portion 414 as opposed to tissue notblocked by the portion 414. While not limited to any particularembodiment, the radioabsorptive portion may be formed by a substance(e.g., Tungsten, Nickel-Titanium alloy, stainless steel) applied to, orimpregnated within, a portion of the tube 412. Alternatively, theradioabsorptive portion(s) may be formed by a liner within, or securedto a portion of, the tube 412. FIG. 4B illustrates a section viewthrough a seed 108 and the tube 412 taken along line 4B-4B of FIG. 4A.

The term “radiotransparent” is used herein to indicate only that theidentified portion of the apparatus or device is relatively moretransparent to radiation than the portion identified as“radioabsorptive.”

FIGS. 5A-5B illustrate a therapy device 502 in accordance with yetanother embodiment. The device 502 is similar in many respects to thedevice 102 described above. For example, the device 502 may include atherapy delivery portion 504 and a tail portion 506 as shown in FIG. 5A.A casing, e.g., heat shrinkable tube 512, may be used to encase theseeds 108 and optional spacers 110 as well as to form the tail portion506. However, unlike the previous embodiments, the therapy device 502may incorporate an anchor member, e.g., a flat or round cross-sectionanchor wire 514, which extends along at least a part of the therapydelivery portion 504. The anchor wire 514 protrudes from one or bothends of the therapy delivery portion and may be bent or otherwise formedto provide one or more hooks, barbs, or other anchors 516.

When the therapy delivery portion 504 exits the needle 114 (see FIG. 1)during implantation, the anchors 516 may extend and engage surroundingtissue, thereby assisting in preventing proximal migration of thetherapy device 502. While only a single anchor is shown at each end ofthe therapy delivery portion 504, other embodiments may include multipleanchors at one or both ends to further resist movement, e.g., rotatingor twisting, distal migration, and the like. FIG. 5B illustrates asection view through a seed 108 and the tube 512 taken along line 5B-5Bof FIG. 5A.

After the desired dose of radiation has been delivered, the therapydevice 102 (or any of the other therapy devices described herein, e.g.,devices 402 or 502), may be removed in any number of ways. For example,the device 102 may be removed by first removing any dressing (e.g.,bandage 2600 of FIG. 2E) and locking member(s) 120, and then simplyapplying a pulling force to one of the tail portions 106 that extendsoutside of the body 200. Alternatively, the devices 102 may be removedprior to or during excisional surgery of the tumor 202 via knownmethods, e.g., via methods similar to excision utilizing localizationwires.

Where the therapy device 102 includes internal retaining elements, e.g.,anchors 516 of device 502 (FIG. 5A), a removal catheter 550 as shown inFIG. 5C may be used. The removal catheter 550 is similar in mostrespects to the delivery cannulae and needles described herein, e.g.,needle 114. The catheter 550 may be threaded over the tail portion 106and advanced until it encompasses the therapy delivery portion 104. Forexample, the removal catheter 550 may be advanced until its distal endengages the distal retaining element(s), e.g., distal anchor 516 of FIG.5A. Further advancement of the removal catheter 550 may bend the anchorsufficiently to permit the therapy delivery portion to slide into theremoval catheter as shown in the broken line representation of FIG. 5C.The device 502 and the removal catheter 550 may then be withdrawn as aunit from the body.

With any of the methods described herein, the time that thebrachytherapy devices remain implanted may vary according to the desiredtherapy regimen. While not wishing to be bound to any fixed period,implantations from about one hour up to about eight weeks or more arecontemplated for therapy. However, for breast brachytherapy,implantation periods ranging from about one day to several weeks, e.g.,four to ten days, are more likely. Moreover, because of the constructionof the devices, e.g., devices 102, they may be removed over a range oftimeframes subsequent to implantation. This is in contrast to thepermanent placement typically associated with conventional LDRbrachytherapy and the short exposure time associated with conventionalHDR brachytherapy. As a result, intermediate activity radiation sourcesmay be utilized with the methods and apparatus described herein, as wellas conventional low and, as further described below, high activitysources.

FIG. 6 illustrates a brachytherapy kit or apparatus 600 in accordancewith another embodiment. Unlike the apparatus 100 of FIG. 1, theapparatus 600 may include, among other components, at least a removablyimplantable brachytherapy treatment device (brachytherapy device 602), apusher or pusher member 620, a catheter, e.g., cannula or cannula member630, and a sharp obturator 640.

The therapy device 602, once again, may include a therapy deliveryportion 604 and a removal or tail portion 606. The therapy deliveryportion 604 may include one or more seeds 108 and optional spacers 110.The seeds 108 may be enclosed within a casing, e.g., heat-shrinkabletube or tube member 612, similar in most respects to the tube 112described above.

The tail portion 606 in this embodiment, however, is formed by anelongate filament or wire, e.g., a non-dissolving surgical suture 614,coupled or otherwise attached to the therapy delivery portion 604. Whilemost any method of attaching the suture 614 to the therapy deliveryportion 604 is possible, one embodiment forms a knot 616 in the suture.The knot 616 may be captured when the tube 612 is heat-shrunk to thetherapy delivery portion 604. In other embodiments, the suture 614 maybe knotted around or otherwise attached directly to the therapy deliveryportion 604. Such suture attachment methods are exemplary only, however,as most any other method of attaching the suture 614 to the therapydelivery portion 604 is possible. The suture 614, as with the tailportion 106 described above, may be made from a non-dissolving material,e.g., polypropylene, polyester, polyamide, and the like.

The pusher member 620 may include a lumen through which the therapydevice 602 may pass as indicated in FIGS. 6 and 7. The pusher member mayinclude a suture locking device 622, e.g., a luer hub, at a proximal endto assist with loading and securing of the therapy device 602. Thelocking device 622 may secure the suture 614 relative to the pusher 620,as further described below. While illustrated as a luer hub, the lockingdevice 622 may include most any friction or clamping device known in theart. For example, the locking device may be an O-ring that may beselectively compressed to pinch the suture 614.

The cannula member 630 may also include a lumen through which the pushermember 620 may pass, as indicated in FIG. 6. The cannula member 630 mayinclude a luer hub 632 at its proximal end that is operable to securethe cannula member relative to the either the sharp obturator 640 or thepusher member 620 when either is slid into the lumen of the cannulamember, as further described below.

The sharp obturator 640 may include a handle portion with a hub 642 at aproximal end, and a sharp point 644 operable to pierce body tissue atits distal end. The handle portion may permit comfortable manipulationof the obturator 640. The external diameter of the obturator 640 may besized so that it fits within the lumen of the cannula member 630, asindicated in FIG. 6.

The components of the apparatus 600 may be made from most any suitablebiocompatible material. For example, the cannula member 630, the pushermember 620, and the sharp obturator 640 may be made from metal, e.g.,stainless steel or Titanium, plastic, or composite materials.

FIG. 7 illustrates the apparatus 600 as it may be assembled before use.The sharp obturator 640 may be placed in the cannula 630 such that thesharp distal end 644 of the obturator protrudes from the distal end ofthe cannula 630, as illustrated. The therapy device 602, which includesthe therapy delivery portion 604 and the suture 614 as described above,may be positioned within the pusher member 620 such that the therapydelivery portion 604 extends from its distal end and the suture 614extends from the hub 622 at its proximal end. The suture 614 may bepulled from the proximal end of the pusher member 620 until the therapydelivery portion 604 is at or near the distal end of the pusher member620, as shown. The locking device 622 may then be engaged to hold thesuture 614, and thus the therapy delivery portion 604, in place relativeto the pusher member 620.

FIGS. 8A-8E illustrate an exemplary method of using the system 600 fordelivering brachytherapy to a portion of a body, e.g., breast 200. Oncethe target tissue region 202, e.g., tumor or tumor cavity, isidentified, the combined cannula 630 and sharp obturator 640 (see FIG.7) may be advanced into the target tissue region 202, as illustrated byarrow 802 in FIG. 8A. When the distal end of the cannula 630 reaches thedesired depth, the sharp obturator 640 may be removed (moved in thedirection 804) through the proximal end of the cannula, as shown in FIG.8B, while leaving the cannula 630 in place.

The combined pusher member 620 and therapy device 602 (see FIG. 7) maythen be inserted into the proximal end of the cannula 630, in thedirection 806, as shown in FIG. 8C. The pusher member 620 and therapydevice 602 may be inserted until the therapy portion 604 is at itsdesired location, e.g., at or near the distal end of the cannula 630.Location of the therapy portion 604 may be assisted by image guidance,e.g., stereotactic X-ray, ultrasound, CT, and the like.

Once the therapy portion 604 is positioned, the cannula 630 may beretracted (moved in the direction 808), exposing the therapy portion 604to the target tissue region 202, as shown in FIG. 8D. The locking device622 may then be unlocked such that the pusher member 620 and cannula 630may be fully withdrawn (moved in the direction 810) from the body 200,as shown in FIG. 8E. The therapy delivery portion 604 remains implantedat the target tissue region 202 while the suture 614 extends outside thebody.

These steps may be repeated for placement of each brachytherapy device602, or multiple devices may be implanted substantially simultaneouslyas a group, as further described below.

Although not illustrated, a locking member, such as the locking member120 illustrated in FIGS. 2E and 27, may be used to secure the therapydevice 602, e.g., the tail portion(s) 606, at one or both (see FIG. 2F)ends. Alternatively, the therapy device 602 may include securingelements, such as the anchors 516 shown in FIG. 5. Still further, thetherapy device 602 may be secured simply by folding and adhering thetail portions 606 to the breast 200 (see FIGS. 2E and 26).

After the desired dose of radiation has been delivered, the therapydelivery device 102 may be removed in any number of ways as alreadydescribed herein, e.g., using a removal member, such as the tail portion606, or a removal cannula.

FIG. 9A is an enlarged view of the therapy device 602 of FIGS. 6-7. Asclearly illustrated in this view, the therapy device 602 may include thetherapy delivery portion 604 and the tail portion 606. The therapydelivery portion 604 may include one, or preferably more, radioactiveseeds 108 securely retained within the casing, e.g., heat-shrinkabletube 612. The tail portion 606 may be formed by the suture 614. The knot616 of the suture 614 may be secured to the therapy delivery portion 604by the heat shrinkable tube 612. While shown as utilizing spacers 110,they may not be required in some embodiments, e.g., the conformalproperties of the casing, e.g., tube 612, may be sufficient to ensureproper seed 108 spacing and containment. FIG. 9B illustrates a sectionview of the seed 108 and tube 612 taken along line 9B-9B of FIG. 9A.

FIGS. 10A-10B illustrate a therapy device 1002 in accordance withanother embodiment. The device 1002 is similar in many respects to thedevice 602 described above. For example, the device 1002 may include atherapy delivery portion 1004 and a tail portion 1006. A casing, e.g.,heat shrinkable tube 1012, may be used to encase the seeds 108 andoptional spacers 110. Like the device 602, the tail portion 1006 may beformed by a suture 614 having a knot 616 that may be heat shrinkable tothe therapy delivery portion 1004. However, unlike the device 602 ofFIGS. 9A-9B, the tube 1012 may include a radioabsorptive portion 1014positioned along a part of the circumference of at least the therapydelivery portion 1004 (see FIG. 10B). The radioabsorptive portion 1014,which may be formed integrally or separately with the tube 1012, maylimit radiation exposure to tissue blocked by the radioabsorptiveportion. FIG. 100B illustrates a section view of the seed 108 and tube1012 taken along line 10B-10B of FIG. 10A.

FIGS. 11A-11B illustrate a therapy device 1102 in accordance with yetanother embodiment. The device 1102 is similar in many respects to thedevice 602 described above. For example, the device 1102 may include atherapy delivery portion 1104 and a tail portion 1106. A casing, e.g.,heat shrinkable tube 1112, may be used to encase and constrain the seeds108 and optional spacers 110. Like the embodiment illustrated in FIGS.5A and 5B, the therapy device 1102 may incorporate an anchor member,e.g., anchor wire 1114, which extends along at least a part of thetherapy delivery portion 1104 and protrudes from one or both ends. Theanchor wire 1114 may be bent at one or both ends to form anchor 1116.When the therapy delivery portion 1104 exits the cannula 630 (see FIG.81D), the anchor 1116 may extend and capture surrounding tissue, therebyassisting in preventing migration of the therapy device 1102. FIG. 11Billustrates a section view of the seed 108 and tube 1112 taken alongline 11B-11B of FIG. 11A.

It is to be understood that any of the various components of theinvention described herein may be used interchangeably with any of thedescribed methods and systems. For example, any one of the devices 102,152, 402, 502, 602, 1002, and 1102 could be used with the methodsdescribed in FIGS. 2A-2E, 2F, and 8A-8E without departing from the scopeof the invention.

The embodiments described above utilize a therapy delivery portion(e.g., portion 104 of FIG. 1 or portion 604 of FIG. 6) formed primarilyby the shrink fit tube (e.g., tube 612 of FIG. 9A) and seeds 108.However, other embodiments of the therapy delivery portion may includean additional support member. The support member may be any materialthat lends support to the therapy delivery portion, e.g., a strip ofmaterial such as stainless steel or superelastic nickel titanium alloy.In addition, to partially support the seeds 108, the material of thesupport member may divide the therapy delivery portion into aradiotransparent portion and a radioabsorptive portion. That is, it maypartially surround at least a portion of the seeds 108 to provide somedegree of attenuation or shielding of radiation to surrounding tissue.As a result, tissue on a side of the support member opposite the seeds108 may receive a lower dose of radiation than tissue on the seed side.The support member may be enclosed within the casing, e.g.,heat-shrinkable tube 112 or 612.

For example, FIGS. 12A and 12B illustrate a therapy device 1202 having atail portion 1206 and a therapy delivery portion 1204 with a pluralityof seeds 108 and a straight support member 1210 (see FIG. 12A). Thesupport member 1210 may have a curved, e.g., arc-shaped, cross-section(see FIG. 12B). Alternatively, a relatively flat cross-section (notshown) may be provided. Other embodiments may utilize most any othercross-sectional shape, e.g., v-shaped. The support member 1210 may alsohave a variety of leading edge shapes including the shovel-tip shapeillustrated in FIG. 12A. At least a portion of the support member 1210may be encased within a casing, e.g., heat shrinkable tube 1212, asalready described above.

While the support member 1210 of FIG. 12A is generally straight, othersupport members may be provided that are curved, e.g., have some degreeof curvature. For example, FIG. 13A illustrates a therapy device 1302having a therapy delivery portion 1304 with a curved support member 1310that imparts an arc-shaped or otherwise curved-shape to the deliveryportion 1304. The support, member 1310 may be formed to have curvaturein its relaxed state or may simply be sufficiently flexible to permitcurved implantation. As with the support member 1210 of FIGS. 12A-12B,the support member 1310 may have most any cross-sectional shape, e.g., aflat shape, curved shape (as shown in FIG. 13B), v-shape, and the like.At least a portion of the support member 1310 may be encased within acasing, e.g., heat shrinkable tube 1312, similar to the casings alreadydescribed above. FIG. 13B illustrates a section view taken along line13B-13B of FIG. 13A.

While not illustrated herein, optionally, the support members mayinclude one or more slots, e.g., along a centerline, so that seeds maybe placed at least partially within the slot. As a result, a therapydelivery portion that offers more rigidity than the unsupported therapydelivery portions described herein may be obtained while ensuring tissueon both sides of the support member receives radiation treatment.

FIGS. 14A-14B illustrate another exemplary embodiment of a therapydelivery portion 1404. In this embodiment, the therapy delivery portionincludes a catheter or casing, e.g., tube 1412, having one or morelumens. A first or main lumen 1408 may receive the seeds (not shown),while a second lumen 1414 may contain an attenuating or shieldingelement 1416 extending over a longitudinal length of the tube 1412. As aresult, the tube 1412 may have a radiotransparent portion (that portionnot blocked by the element 1416), and a radioabsorptive portion (thatportion shielded by the element 1416). In one embodiment, the tube 1412can be made by co-extruding plastic (e.g., fluoropolymer) with anattenuating material such as strands of fine metallic wire (e.g.,stainless steel, gold). In another embodiment, the attenuating materialmay be a coextrusion of polymer loaded with an attenuating material suchas Tungsten powder. The tube 1412 may or may not be heat-shrinkable. Forversatility, the shielding element 1416 may be straight or preformed ina curve. FIG. 14B illustrates a section view taken along line 14B-14B ofFIG. 14A.

FIG. 15 is a partial view of an exemplary brachytherapy apparatus 1500having a therapy device 1502 and catheter, e.g., cannula 1501, whereinthe device 1502 includes a curved therapy delivery portion 1504, and atail portion 1506. Other components of the system, e.g., pusher memberand sharp obturator, are not illustrated in this view merely forclarity. The curved therapy delivery portion 1504 may be formed by acurved support member, such as support member 1310 of FIG. 13A. Thecannula 1501 preferably has a lumen diameter sufficiently large toaccommodate the curved therapy delivery portion 1504 when the latter isconstrained in a straightened configuration for delivery. Alternatively,the cannula 1501 may be sized to receive the therapy delivery portion1504 in its curved configuration. In still yet other embodiments, thetherapy delivery portion 1504 may be generally straight but flexible andthe cannula 1501 used to deliver the therapy delivery portion may becurved.

Non-linear (e.g., curved) catheters may also be used for deliveringand/or placing the brachytherapy devices described herein to regions andpositions inaccessible to straight catheters. For example, FIGS. 16A-16Eillustrate an exemplary apparatus 1650 and method operable to implant abrachytherapy device, e.g., device 102 of FIG. 1, along a non-linearaxis. FIG. 16A illustrates the apparatus 1650 including a first cathetermember, e.g., needle 1652, a second catheter member, e.g., flexiblecatheter 1656, and a brachytherapy device 102. The needle 1652 includesan off-axis opening 1654 at or near a distal end of the needle. Theneedle 1652 may be inserted into the body 200, in the direction 1651,until the distal end is positioned past the target tissue region 202 asshown in FIG. 16A. The flexible catheter 1656 may then be insertedthrough the needle 1652 (in the direction 1653) until a distal end 1667of the catheter 1656 protrudes from the opening 1654 of the needle 1652at an angle 1661 as shown in FIG. 16B. That is, an axis of the catheter1656 may intersect, or be otherwise nonparallel to, an axis of theneedle 1652.

The angle 1661 between the axes may vary, but angles ranging fromgreater than about zero degrees to about ninety degrees (0-90°), andmore preferably about five degrees to about thirty five degrees (5-35°),are contemplated.

The device 102 may then be threaded through the catheter 1656 (in thedirection 1655), as shown in FIG. 16C, until the therapy deliveryportion of the device 102 is located at or near the distal end 1667 ofthe catheter 1656.

At this point, the catheter 1656 may be withdrawn slightly (in thedirection 1669), as shown in FIG. 16D, exposing the therapy deliveryportion of the device 102. The needle 1652 and catheter 1656 may then bewithdrawn (in the direction 1671) from the body 200 together as shown inFIG. 16E. The device 102 is then implanted on a non-linear axis with itstail portion 106 extending outside the body as generally described abovewith reference to other embodiments (see e.g., FIGS. 2A-2E).

The ability to implant the device 102 along a non-linear axis may bebeneficial in many applications. For example, where the target tissueregion 202 is a breast lesion or a lumpectomy cavity in the breast, thenon-linear device 102 may provide the capability to better focusradiation. Further, non-linear positioning may permit implantationaround obstructions in the body. For example, in prostate brachytherapy,the region 202 could be a pubic arch around which the clinician desiresto place radiation sources. While described above with respect todevices 102, the non-linear placement of FIGS. 16A-16E could also beused to implant individual radiation sources.

In yet other embodiments of non-linear placement apparatus andtechniques, the needle 1652 of FIGS. 16A-16E may be replaced with a morespiral-shaped needle 1675 as shown in FIGS. 16F and 16G. While theactual needle size may vary depending on target tissue volume, needleshaving a helix diameter of about three centimeters (3 cm) arecontemplated. The needle 1675 may be advanced into the body 200 in muchthe same way a corkscrew is inserted into a cork. That is, the needle1675 may be rotated in a direction 1678 such that a sharp end 1676penetrates the body 200 as indicated in FIG. 16F. FIG. 16G illustratesthe needle 1675 once it is fully inserted. A flexible catheter (notshown) and therapy device (also not shown) may then be passed throughthe needle 1675 in much the same way as the catheter 1656 and device 102are described with reference to FIGS. 16A-16E. The needle 1675 may thenremoved (“unscrewed”), leaving the therapy device in a spiralconfiguration around the target tissue region 202 (not illustrated).

When non-linear, e.g., off-axis, curved, and spiral, therapy deliveryportions are used, the total number of therapy devices required to treata given target tissue region may potentially be reduced as a result ofthe delivery portions conformance to the shape of the target tissue. Forexample, in the case of curved delivery portions, several devices may beplaced to curve around the target tissue region, effectively focusingradiation on a central area. This may result in lower dose exposureoutside of the target tissue area, and potentially improved dosecoverage within the target tissue. In the case of a spiral therapydelivery portion, a single therapy device of sufficient length maydeliver adequate treatment by spiraling (e.g., forming a helix) aroundor within the target tissue region.

FIGS. 17A-17B illustrate an apparatus 1600 similar in most respects toapparatus 600 of FIG. 6. For instance, it may include a therapy device1602 having a therapy delivery portion 1604 with seeds 108, and tailportion formed by a suture 1614. The suture 1614 may pass through apusher member 1620 and the combined pusher member 1620 and deliverydevice 1602 may be placed within a cannula 1630. Unlike the cannula 630,however, the cannula 1630 may have a cutout 1634, e.g., the cannula mayhave a C-shaped cross section, as shown more clearly in FIG. 17B, overat least a portion of its length. While shown as straight, the cannula1630 may also be curved. The cutout configuration may protect certainsurrounding tissues/organs, e.g., skin, chest wall, liver, heart, duringimplantation. FIG. 17B is a cross-section taken along line 17B-17B ofFIG. 17A with the therapy delivery device 1602 also shown in brokenlines.

During implantation of any of the devices described herein, the patientmay optionally wear a protective garment, e.g., a chest coveringbrassiere or binder 1900, such as that illustrated in FIG. 18. Thebrassiere/binder 1900 may be similar in many respects to those garmentsdescribed, for example, in U.S. Pat. Nos. 3,968,803 to Hyman; 5,152,741to Farnio; and 5,538,502 to Johnstone, the disclosures of which areexpressly incorporated by reference herein. For example, it may includea partial body covering that secures via fasteners, e.g., shoulderstraps 1904, to cover a portion of the chest (or other area surroundingthe target tissue region). However, in addition to a fabric portion1906, the binder 1900 may include a lining made from a radiationattenuating material 1902, e.g., lead, stainless steel, Tungsten. Such agarment may offer an added degree of shielding and permit greaterpatient mobility, while the indwelling radioactive sources, e.g., seeds108, are held in their proper position, in an out-patient setting. Thegarment 1900 may be provided separately, or as part of a brachytherapykit, e.g., kit 100.

Although discussed above primarily with respect to LDR brachytherapy,the apparatus and/or methods described herein may also find use in HDRapplications. For example, the tube 1412 of FIGS. 14A-14B may be used asa shielded delivery catheter for HDR treatment, e.g., the tube 1412 maybe located in the body and a conventional HDR source (e.g., afterloadHDR cable) of smaller diameter may be passed through the main lumen1408. The attenuating element 1416 in the wall of the catheter (along acircumferential portion extending from about 10 o'clock to about 2o'clock, for example) may attenuate the radiation exposure of regionsvulnerable to radiation while the non-shielded section of the tube 1412(along a circumferential portion extending from about two o'clock toabout ten o'clock) may allow exposure to the target tissue.

Further, for example, HDR radiation sources may be passed through acatheter, e.g., the cannula 1630 of FIGS. 17A and 17B, whereby the HDRradiation sources may be partially shielded from surrounding tissue bythe geometry of the cannula 1630, e.g., the cutout 1634.

FIGS. 19A-19C illustrate incorporation of a HDR shielded catheter on aballoon-type brachytherapy treatment device 1800. The device 1800 may besimilar to the device disclosed in U.S. Pat. No. 5,913,813 to Williamset al., the disclosure of which is expressly incorporated by referenceherein. For example, it may include a brachytherapy catheter assembly1802 having a catheter shaft 1814 with a proximal end and a distal end.An inflatable balloon 1806 may be coupled to the catheter shaft 1814between the proximal end and the distal end. An inflation lumen 1830 mayextend along the catheter shaft 1814 between the inflatable balloon 1806and the proximal end to allow inflation of the balloon. A dose deliverylumen 1804 (see FIG. 19B) may also be provided and extend along thecatheter shaft 1814 from the proximal end towards and the distal end,e.g., extending between the inflatable balloon 1806 and the proximalend.

In use, the distal end of the catheter shaft 1814 may be placed into acavity, e.g., a lumpectomy cavity 1808 of breast 200, and the balloon1806 inflated. A radiation source (not shown) may then be passed throughthe dose delivery lumen 1804, where it delivers radiation along a dosedelivery portion of the catheter shaft, e.g., along a portion surroundedby the inflatable balloon 1806. By incorporating a radioabsorptiveportion (e.g., arc-shaped member 1811 clearly illustrated in FIG. 19C)over the dose delivery portion of the catheter shaft 1814, only apredetermined portion, e.g., a window 1817, of the dose delivery portionmay be relatively radiotransparent. As a result, the device 1800 mayattenuate the radiation exposure of select areas, e.g., those close tothe skin or chest wall, while delivering higher radiation levels totarget tissue not blocked by the radioabsorptive portion 1811. While theradioabsorptive portion is illustrated herein as a separate member 1811extending along a portion of the catheter shaft 1814, other embodimentsmay incorporate the radioabsorptive portion into the catheter shaft 1814itself (e.g., the catheters described elsewhere herein, such as the tube1412 of FIGS. 14A-14B).

In some embodiments, the device 1800 may further include a vent systemhaving one or more vents 1810 positioned around at least a portion of anouter surface of the balloon 1806. The vents 1810 may permit air andfluids within the cavity 1808 to escape as the balloon 1806 expands. Oneor more vent lumens 1812 (shown in FIG. 19B) associated with thecatheter shaft 1814 may extend between the proximal end of the cathetershaft 1814 and the one or more vents 1810. The vents 1810 may fluidlycommunicate with one or more vent lumens 1812, thereby allowing the airand fluids to exit the body at the proximal end of the catheter shaft1814 during and after balloon expansion.

In some embodiments, the external vents 1810 and vent lumens 1812 areformed by individual pieces of tubing 1816 attached to the balloon 1806and catheter shaft 1814. In the vicinity of the balloon 1806, the tubing1816 may be perforated to form the external vents 1810. The portion ofthe tubing 1816 located proximate the catheter shaft 1814 may or may notinclude perforations. The tubing 1816 may be formed of most anybiocompatible material that can be securely attached to, or formed with,the balloon 1806 and catheter shaft 1814, e.g., silicone tubing.

FIGS. 20-22 illustrate an exemplary system 1700 for implanting the LDRbrachytherapy devices and their associated radiation sources describedabove to a target tissue region, e.g., the region surrounding a breastlumpectomy cavity. In the illustrated embodiment, the system includes acatheter or needle guiding template 1702 having a predetermined numberand pattern (array) of openings 1704 as shown in FIG. 20. The template1702 may form part of an adjustable catheter or needle guiding apparatusby coupling to a stereotactic table 1720, which is diagrammaticallyillustrated in the figures by base portion 1722, and translating portion1724 (portions 1722 and 1724 shown exploded in FIG. 20). Thestereotactic table 1720 is preferably coupled or attached to a patientlocating or treatment surface 1730, e.g., patient table.

The template 1702 may be coupled to, or otherwise associated with, afirst compression member 1726 located adjacent an opening 1732 in thetreatment surface 1730. An opposing second compression member 1728 maybe located on an opposite side of the opening 1732. The compressionmembers 1726 and 1728 may be oriented about ninety degrees (90°) from aset of optional compression plates 1727 (only one plate 1727 shown).

One or both compression members 1726, 1728 may include a hole patternsimilar to that of the template 1702, or may otherwise at least permitthe passage of the needles/cannulae (e.g., needles 114 of FIG. 1), asillustrated in FIG. 21.

In use, a patient may lie on the treatment surface 1730, e.g., with thepatient's head located in the direction 1731, such that the breast 200passes through the opening 1732 of the treatment surface 1730. Theoptional compression plates 1727 may then be used to immobilize thebreast 200.

Once the breast 200 is immobilized, the stereotactic table 1720, withthe template 1702 attached, may be positioned, and the translatingportion 1724 moved, until the compression members 1726 and 1728 contactthe breast 200. The position of the stereotactic table 1720, and thusthe needle guiding template 1702, may be aligned with the location ofthe target tissue region 202 via the use of various imaging techniquesincluding, for example, X-ray, ultrasound and CT scan. In someembodiments, the template 1702 may be aligned relative to the targettissue region based upon input provided by an imaging device, e.g., aside viewing ultrasound apparatus 1739, located underneath the breast200.

With the template 1702 aligned with the target tissue region 202 andpositioned against the breast 200, one or more needles 114 may beinserted into the openings 1704. In the treatment of breast lesions, theneedles 114 may be inserted completely through the breast 200 asillustrated in FIG. 21. Alternatively, and in the treatment of othercancers, the length of each needle 114 may be varied to ensure thecorrect depth penetration at each opening 1704, or the insertion depthof each needle 114 may simply be varied.

Certain embodiments of the system 1700 may optionally include anadhesive bandage member 1750 associated with the first compressionmember 1726, and/or an adhesive bandage member 1752 associated with thesecond compression member 1728. Preferably, the bandage members 1750 and1752 are located between the respective compression members and thebreast 200. The bandage members 1750 and 1752 may have adhesive on eachside, e.g., a first side 1754 and a second side 1756, and includeopenings (not shown) that correspond generally to the openings 1704 ofthe template 1702. Alternatively, the bandage members 1750 and 1752 maybe punctured by the needles 114 during needle insertion. When thecompression members 1726 and 1728 are pressed against the breast 200,the bandage members 1750 and 1752 may adhere to the breast 200 andprovide a dressing for the punctures created by the needles 114.

Once the needles 114 are inserted, the brachytherapy devices describedherein, e.g., devices 102 or 602, may be inserted, and the needles 114removed, in accordance with various methods as described and illustratedherein. For example, the brachytherapy devices 102 (or devices 602) maybe inserted and the needles 114 (or the cannulae 630) removed inaccordance with the methods described herein and illustrated in FIGS.2A-2E and 2F (or 8A-8E).

With the needles 114 removed, the template 1702 and contact plates 1726and 1728 may be withdrawn from the breast 200, leaving the bandagemembers 1750 and 1752 adhered to the breast by their respective firstadhesive sides 1754. The tail portions 106 may then be anchored, e.g.,by using locking members such as members 120 illustrated in FIGS. 2E and27.

A liner (not shown) may then be removed from the respective secondadhesive side 1756 of each bandage member 1750 and 1752. Once the secondadhesive side 1756 is exposed, the flexible tail portions 106 may befolded against the second adhesive side, where they adhere thereto. Asecond, single-sided adhesive member (not shown) may be placed over eachbandage member 1750 and 1752 to secure the tail portions and cover anyexposed adhesive on the second adhesive side 1756. As a result, theflexible tail portions may be folded against the contours of the breastand secured.

In some embodiments, the openings 1704 of the template 1702 may begrouped according to a particular target tissue volume, e.g., lesionsize, as shown in FIG. 22. For example, a small square, five-openingpattern 1740 may be utilized for small target tissue regions (e.g.,those regions up to about one centimeter (1 cm) in diameter), while alarger nine-opening pattern 1742 may be utilized for larger targettissue regions (e.g., those regions up to about two centimeters (2 cm)in diameter). A still larger, thirteen-opening pattern may be utilizedfor even larger target tissue regions (e.g., those regions up to aboutthree centimeters (3 cm) in diameter).

By aligning the center opening of the template 1702 with the center ofthe target tissue region, the template may indicate a standard number ofseeds, e.g., a particular number of therapy devices 102, based upon thepredetermined target volume. This could simplify, or possibly eliminate,the need for complex dose mapping calculations commonly associated withconventional brachytherapy methods.

It is noted that the patterns 1740, 1742, and 1744 are exemplary only.In other embodiments, the patterns may include most any number ofopenings 1704 in most any shaped pattern, e.g., a circular array of fiveto fifty (5-50) catheters. Moreover, the templates could accommodatemore that one diameter catheter or needle (e.g., ten, fifteen, andtwenty millimeter (10, 15, and 20 mm) diameters). Moreover, while shownwith three patterns, templates having most any number are possiblewithout departing from the scope of the invention.

FIGS. 23 and 24 illustrate another system for implanting brachytherapydevices. FIG. 23 illustrates a system 2300 similar in many respects tothe system 1700 described above. For instance, the system 2300 mayinclude a stereotactic table 2320 secured to treatment surface, e.g.,patient table (not shown). The table 2320 may include a base portion2322 and a translational portion 2324. The system 2300 may also includea first or proximal compression member 2326 and a second or distalcompression member 2328. One or both compression members 2326 and 2328may be movable relative to the other and/or the base portion 2322, e.g.,along a slide rail 2329.

Unlike the system 1700, however, the system 2300 may also include acatheter or needle cartridge receiver 2340 operable to receive apre-assembled needle cartridge 2342 having multiple needles 114positioned in a predetermined array. The needle cartridge 2342 is shownin an exploded view in FIG. 24. The cartridge 2342 may include a firstholder 2344 and a second holder 2346 (second holder 2346 not shown inFIG. 24). The holders 2344 and 2346 may include holes 2348 to hold andguide the multiple needles 114 in the desired predetermined array duringinsertion. Where needles 114 include a hub 116, the holes 2348 in theholder 2346 may be larger than the corresponding holes 2348 in theholder 2344 to permit the passage of the hub 116 (see FIG. 23).

During operation of the system 2300, the stereotactic table 2320 may bealigned as described above with respect to the system 1700. Oncealigned, the breast 200 may be immobilized with the compression members2326 and 2328. Based upon the particular volume of the target tissueregion 202, a specific cartridge 2342 may be selected and pre-assembledwith a corresponding number of catheters, e.g., needles 114. Forinstance, the cartridge in FIG. 24 is a 5 catheter configuration.However, other cartridges may utilize more or less catheters (e.g., 9catheter and 13 catheter cartridges). The cartridge 2342, including theholders 2344 and 2346 and the catheters 114, may then be loaded into thecartridge receiver 2340. Portions of the holders 2344 and 2346 may bedesigned to contact one or more internal surfaces of the cartridgereceiver 2340 so that the cartridge 2342 aligns with the cartridgereceiver upon insertion.

Once the cartridge 2342 is loaded, each needle 114 may be independentlyand manually advanced through the proximal compression plate 2326 (whichmay include a hole pattern identical to the holder 2344), the breast200, and the distal compression member 2328. The central needle 114 maybe advanced first and its position within the target tissue region 202confirmed (or repositioned) before the remaining needles are advanced.Brachytherapy devices, e.g., devices 102 of FIG. 1, may then be placedinto the needles 114, as described in FIGS. 2A-2E. Alternatively, thedevices 102 could be pre-installed in the cartridge 2342.

With the devices 102 inserted completely, the distal tips of the tailportions, e.g., similar to tail portion 106 of FIG. 1, may betemporarily secured relative to the distal compression member 2328. Atthis point, the needles 114 may be retracted and removed from the breast200, and ultimately, withdrawn from the cartridge loader 2340. Theproximal compression member 2326 may then be withdrawn and the proximaltail portions secured to the breast using, for example, the lockingdevices 120 described above and illustrated in FIGS. 2E and 27. Thedistal compression member 2328 may then be withdrawn and the distal tailportions secured relative to the breast 200 in a similar manner.

FIGS. 25A-25D illustrate yet another system and method for inserting thebrachytherapy devices into a target tissue region. FIG. 25A illustratesa system 2500 similar in many respects to the systems 1700 and 2300described above. For example, the system 2500 includes a stereotactictable (not shown) having a catheter or needle cartridge receiver 2540coupled thereto. The stereotactic table is preferably coupled to thetreatment table (also not shown). The system 2500 may also include acatheter or needle cartridge 2542. The needle cartridge 2542 may includea series of needles 2514, e.g., a five, none, or thirteen needle array,which are generally rigidly and orthogonally mounted to a first plungermember 2550. In this embodiment, the needles 2514 may be hubless as theproximal ends of the needles 2514 are secured (e.g., press fit, staked,adhered, etc.) to the first plunger member 2550.

The cartridge 2542 may also include a first or proximal compressionmember 2526 (which may form the needle guiding template) as well as asecond plunger member 2552 and an optional backing plate 2554. In otherembodiments, the backing plate 2554 may be part of the cartridgereceiver 2540. As with the systems previously described herein, thesystem 2500 may also include a second or distal compression member 2528to assist in immobilizing the breast 200.

During operation, the stereotactic table may be aligned such that thecenter of the needle cartridge receiver 2540 is centered relative to thetarget tissue region 202. The cartridge 2542 may then be loaded into thecartridge receiver 2540, and the breast immobilized by the first andsecond compression members 2526 and 2528. The brachytherapy devices,e.g., devices 102 of FIG. 1, may have been previously loaded into theneedles 2514 of the cartridge 2542. The first plunger member 2550 maythen be advanced toward the breast 200. Because the needles 2514 arerigidly coupled to the first plunger member 2550, the needles 2514advance simultaneously into the target tissue region of the breast 200in the pre-determined parallel array. The first plunger member 2550 mayinclude a tab 2560 that rides along a slot or surface 2561 of thecartridge receiver 2540 so that the first plunger member 2550 may bemanually or automatically advanced from outside the cartridge.

After the first plunger member 2550 has been fully advanced as shown inFIG. 25B, the second plunger member 2552 may be advanced toward thebreast 200. The second plunger member 2552 has the proximal tailportions 106 of the brachytherapy devices 102 releasably securedthereto. Thus, advancing the second plunger member 2552 may advance oneor more of the brachytherapy devices 102 into place such that the distaltail portions 106 emerge from the distal ends of the needles 2514 asshown in FIG. 25C.

The distal tail portions 106 may temporarily be secured to the distalcompression member 2528 to hold the brachytherapy devices 102 in place.Once the distal tail portions 106 are secured, the proximal tailportions 106 may be released from the second plunger member 2552 and thefirst and second plunger members 2550 and 2552 may be retracted as shownin FIG. 25D. The cartridge receiver 2540 may also be retracted so thatthe proximal tail portions 106 may be secured in accordance with methodsalready described herein (e.g., locking members 120). The distal tailportions 106 may then be disconnected from the distal compression member2528 and the latter withdrawn. The distal tail portions 106 may then besecured relative to the breast 200.

Thus, the system 2500 provide an apparatus for simultaneouslyimplanting, in a two dimensional array, multiple brachytherapy devicesinto the body. Moreover, the systems described herein allowsimultaneously advancing a two-dimensional array of catheters into atarget tissue region, and then delivering or implanting one or moreradiation sources through at least one of the catheters of the array.Once the radiation sources are implanted, sequential or simultaneousremoval of the catheters of the array of catheters from the targettissue region may be accomplished.

Each radioactive source, e.g., seed 108, of the devices described hereinmay have substantially the same radioactivity level as the other seedswithin the same device. However, any of the embodiments described hereinmay vary brachytherapy by utilizing seeds that have differing levels ofradioactivity within the same brachytherapy device. Stated another way,a first radioactive source (e.g., first seed) of the device may have afirst radioactivity level (e.g., about five millicuries (5 mCi)), whilea second radioactive source (e.g., second seed) of the same device mayhave a second radioactivity level that is less than the firstradioactivity level (e.g., about one millicurie (1 mCi)). Likewise, inmulti-device applications, each seed within a given device could haveidentical radioactivity levels, but different devices within the arraycould contain seeds of different radioactivity levels.

As already described above, some embodiments may permit the tailportions 106 to be secured to the breast using an adhesive pad orbandage 2600 as illustrated in FIG. 26. Here, the bandage may be used inconjunction with, or as an alternative to, the locking members 120.

To assist the healthcare provider in securing the distal and/or proximaltail portions 106, the compression members 2526, 2528 may be configuredas generally illustrated in FIG. 27. For example, openings 2570 in theplate (e.g., plate 2528) through which the tail portions 106 pass mayinclude a recess 2572 that holds the locking member 120 against theskin. As a result, when the compression plate 2528 is withdrawn, thelocking member 120 may already be threaded over the tail portion 106.The healthcare provider may then quickly crimp the locking member 120,e.g., along a deformable portion 2576.

While many of the devices and apparatus described herein are directed tolinear placement, it may be of benefit to locate radioactive sourceswithin a tumor or lumpectomy cavity in a more sophisticated geometry.For instance, devices may be implanted in a non-linear manner asdescribed above with reference to FIGS. 16A-16G. Geometries that arecurved rather than straight may allow better conformance to the targettissue (e.g., better conformance to the tissue surrounding thecurvilinear volume of a lumpectomy cavity).

Moreover, apparatus, devices, and systems in accordance with otherembodiments described herein may permit implantation of brachytherapydevices in a first or collapsed, e.g., substantially straight,configuration, after which they may be externally actuated to a secondor deployed, e.g., curvilinear, configuration once located within thetarget tissue region, e.g., within a lumpectomy cavity. Statedalternatively, such embodiments may provide a brachytherapy treatmentapparatus for insertion into the target tissue region of a body, e.g.,breast, wherein the apparatus includes one or more brachytherapy deviceshaving one, and preferably more, radioactive sources such as thosealready described herein (e.g., see device 102). The brachytherapydevice may be inserted into the target tissue region in a generallylinear configuration. However, it may then be subsequently reconfiguredto produce a curvilinear array of radioactive sources, e.g., as furtherdescribed below.

Such apparatus and devices may permit implantation through a single,minimally-sized incision, yet may subsequently deploy in-situ to providea dose delivery region that is geometrically better suited to thecurvilinear shape of the target tissue (e.g., the region of tissuesurrounding the lumpectomy cavity). In addition, the deployedconfiguration may provide a broader array from which radiation sourcesmay deliver their desired dose, as compared to the first collapsedconfiguration.

Additionally, in-situ deployable apparatus, devices, and systems asdescribed herein may enhance fixation of the radiation sources within aspecific location of the lumpectomy cavity. Fixation is beneficial inthat it provides a substantially fixed geometry between the implantedradiation sources and the surrounding target tissue. By minimizingmovement of the radiation sources (relative to the target tissue) duringsubsequent patient activity, brachytherapy exposure may more closelyfollow pre-implant dose planning regimens.

One embodiment of such a deployable apparatus is diagrammaticallyillustrated in FIGS. 28A-28D by an expanding cage-type apparatus 2800.Generally, the intracavitary apparatus 2800 includes a therapy deliveryportion 2800 a, which may be deployed within a target location of apatient's body, e.g., tumor or cavity within a breast or other bodystructure 200, and a tail portion 2800 b, which extends from the therapydelivery portion 2800 a, e.g., such that the tail portion 2800 bprotrudes outside of the body structure 200. As shown in FIGS. 28A-28D,the therapy delivery portion 2800 a may be movable between a collapsedconfiguration, e.g., for introduction through a tissue tract to a targetlocation, and an expanded configuration, e.g., for providing a threedimensional array of pathways at the target location 2802, as describedfurther below.

Optionally, the apparatus 2800 may include a sheath or other cover (notshown), which may overly the therapy delivery portion 2800 a, e.g.,until deployment. In addition or alternatively, a tubular deliverydevice, such as catheter, cannula, or needle 2804, may be provided forintroducing the apparatus 2800 into the target location. A trocar orother instrument (not shown) may be disposed within the needle 2804 suchthat a sharpened tip (also not shown) of the trocar extends beyond adistal end 2804 a of the needle 2804 to facilitate insertion of theneedle 2804 through tissue, e.g., to create a tissue tract from thepatient's skin to the target location. The trocar may be removed aftercreating the tract, thereby allowing the apparatus 2800 to then beintroduced into the needle 2804.

Alternatively, the needle 2804 may include a sharpened distal tip (notshown). In this alternative, the trocar may be eliminated, and,optionally, an obturator or other instrument (also not shown) may beinitially provided to occlude the lumen while the needle 2804 isadvanced through tissue. After removing the obturator, the apparatus2800 may be introduced into the needle 2804, e.g., directly or carriedwithin a sheath or cover (not shown).

In a further alternative, the apparatus 2800 may include a sharpeneddistal tip (not shown), e.g., similar to other embodiments describedbelow. The distal tip may extend beyond the distal end 2804 a of theneedle 2804, thereby creating the tract when the needle 2804 andapparatus 2800 are advanced together through tissue. In yet anotheralternative, the apparatus 2800, with a sharpened distal tip, may beadvanced directly through tissue to create the tissue tract, and theneedle 2804 may be eliminated.

FIG. 28A illustrates the brachytherapy apparatus 2800 after insertionthrough an incision in the body. The apparatus 2800 is positioned suchthat the therapy delivery portion 2800 a is located within a hollowtarget region, e.g., lumpectomy cavity 2802. As illustrated in FIG. 28A,a catheter or needle 2804 has been inserted through the body structure,e.g., breast 200, and into the cavity 2802. Once the apparatus 2800 isin place, the needle 2804 may be retracted or removed, exposing thetherapy delivery portion 2800 a.

As shown, the therapy delivery portion 2800 a includes a plurality ofradioactive brachytherapy devices, e.g., flexible, elongate members 2806including proximal and distal ends 2806 a, 2806 b and configured forcarrying one or more radiation sources. The apparatus 2800 includes ahub or outer body member 2807 to which the proximal ends 2806 a of theelongate members 2806 are secured, as shown in FIG. 28B. The distal ends2806 b of the elongate members 2806 may be fixed or otherwise retainedat a distal end 2808 of a core member 2810. As shown, the core member2810 extends through the body member 2807 such that a proximal end 2812of the core member 2810 extends out of the body structure 200.Alternatively, a handle (not shown) may be coupled or otherwise extendproximally from the core member 2810.

The hub and core member 2810 may be movable axially relative to oneanother to expand and/or collapse the therapy delivery portion 2800 a.For example, by manipulation of the proximal end 2812 of the core member2810 and the body member 2807, e.g., by displacing the core member 2810in a first (proximal) direction 2814 and/or the body member 2807 in asecond (distal) direction 2816, the elongate members 2806 may beexpanded within the volume of the cavity 2802, as shown in FIG. 28C.When fully expanded, the elongate members 2806 may contact walls of thecavity 2802, as shown in FIG. 28D, and/or push into tissue surroundingthe walls of the cavity 2802, as described further below.

FIGS. 29A-29F illustrate another embodiment of an in-situ deployablebrachytherapy apparatus 2900. The apparatus is similar in many respectsto the apparatus 2800 described above. For example, the apparatus 2900may include an expandable cage of radioactive brachytherapy devices,e.g., flexible, elongate members 2906. Each elongate member 2906 may, ata distal end 2906 b, couple to a hub 2909 and, at a proximal end 2906 a,couple to a body member 2907. A flange 2914 may be provided at aproximal end of the body member 2907, as shown in FIG. 29A. A coremember 2910, also coupled to the hub 2909, may extend through the bodymember 2907 and past the flange 2914, terminating at a button or otherhandle 2912.

The elongate members 2906 may terminate, at their proximal ends 2906 a,within the body member 2907. However, as explained further below, otherbody member embodiments may include passageways that provide access tolumens formed in the elongate members 2906 from a proximal side of theflange 2914.

The apparatus 2900 may be moved from a first collapsed configuration,wherein the elongate members 2906 are generally straight and parallel toa central axis of the core member 2910 (see FIG. 29B), to a seconddeployed configuration, as shown in FIGS. 29A and 29C, wherein theelongate members 2906 are curvilinear. For example, movement to thedeployed configuration may be achieved by moving the flange 2914, andthus the body member 2907, away from the button 2912 (i.e., in thedistal direction 2916). Similarly, the apparatus 2900 may be collapsedby moving the flange 2914 towards the button 2912 (i.e., in the proximaldirection 2918).

It will be appreciated that other actuators may be provided in additionto the flange 2914 and button 2912. For example, the core member 2910and body member 2907 may include mating threads (not shown), e.g., on aninner surface of the body member 2907 and an outer surface of the coremember 2910 within the body member 2907. Rather than axial movement ofthe button 2912, the button 2912 may be rotated in a first direction,thereby causing the body member 2907 to move axially, i.e., distally,over the core member 2910 to expand the elongate members 2906 to theexpanded configuration. The button 2912 may be rotated in a secondopposite direction to collapse the elongate members 2906 back to thecollapsed configuration.

Optionally, in any of these embodiments, the button 2912 and/or portionof the core member 2910 beyond the flange 2914 may be detachable fromthe rest of the core member 2910 (within the body member 2907 andextending to the hub 2909), e.g., to reduce a profile of the apparatus2900 after implantation. For example, the core member detachable portionand remaining portion (not shown) may include mating male/female ends,e.g., connected by threads or other releasable connectors (also notshown). Alternatively, a barrel or other structure may be disposedwithin the body member 2907 that is coupled to the proximal ends 2906 aof the elongate members 2906 such that axial movement of the barrelrelative to the body member 2907 causes expansion or collapse of theelongate members 2906.

In another option, the core member 2910 (and/or actuator) may includeone or more stops (not shown) to limit movement of the body member 2907,e.g., to limit expansion of the elongate members 2906. The stops mayprovide a maximum size for the expanded configuration or may provide arange of sizes through which the elongate members 2906 may be expandedand fixed. For example, ratchets or detents (not shown) may allow thebody member 2907 to be moved, yet maintained at a position to which thebody member 2907 is moved relative to the core member 2910.

FIGS. 29B and 29C illustrate the brachytherapy apparatus 2900 afterinsertion through an incision in the body structure, e.g., breast 200.The apparatus 2900 may be positioned such that its distal end, e.g., hub2908, is located within the lumpectomy cavity 2902. In the illustratedembodiment, the apparatus 2900 is inserted through an existing incision.However, the apparatus 2900 may have features (e.g., a sharp distal tip)that permit it to make its own incision, as described above. The sharpdistal tip may enable the tip of the apparatus 2900 to be positionedbeyond the edge of the cavity, e.g., in order to position the expandedelements in an optimal position within the cavity.

In some embodiments, the apparatus 2900 may include a tear-away sheath(not shown) that covers the elongate members 2906 during handling and/orimplantation. After the apparatus 2900 is positioned as shown in FIG.29B, the sheath may be removed (e.g., using a tear-strip positionedoutside the body and/or one or more weakened seams or regions extendingalong the sheath) to expose the elongate members 2906.

Once the apparatus 2900 is in place, e.g., as shown in FIG. 29B, thephysician may displace the flange 2914 towards the body (in the distaldirection 2916). Similarly, the button 2912 may be displaced proximallyaway from the flange 2914. This motion causes the elongate members 2906to deploy, as shown in FIG. 29C, within the volume of the cavity 2902.When further expanded, the elongate members 2906 may contact the wallsof the cavity and, when fully expanded, may press into the surroundingtissue sufficiently to cause the cavity walls to reconfigure in aninterdigitating manner between the members 2906 (see, e.g., FIGS.32D-32G, as described further below). This interdigitation orinvagination of the walls results in generally fixing the apparatus 2900relative to the tissue surrounding the cavity 2902.

As used herein, the terms “invagination” and “interdigitation” refer topressing of one or more portions or elements of the apparatus 2900outwardly from within a cavity 2902, into the tissue surrounding thecavity 2902, such that tissue adjacent the elements flows, folds, orextrudes inwardly between the elongate members 2906. FIGS. 32D-32H, forexample, illustrate this concept. In addition to being substantiallysurrounded by tissue, one or more of the elongate members 2906 maypenetrate into the surrounding tissue, e.g., such that the elongatemember(s) 2906 may be completely surrounded by tissue, as describedfurther below.

FIG. 29D is a cross-sectional view of the apparatus 2900, taken alongline 29D-29D of FIG. 29C. As shown in this view, the elongate members2906 may be tubular members including one or more lumens, e.g., a firstlumen 2918 and a second lumen 2920. The first lumen 2918 may be sized toreceive a brachytherapy device, e.g., similar to the devices 102, 152,402, 502, and 602 already described elsewhere herein. The second lumen2920 may, on the other hand, be configured to hold a stiffening member(not shown). The stiffening member may assist in maintaining the properorientation of the elongate members 2906, e.g., may assist in ensuringthat the lumens 2918 (and, thus, the brachytherapy devices) aresufficiently stiff so as to prevent their deflection during expansioninto the surrounding tissue and/or ensure that the elongate members 2906expand substantially in a predetermined configuration.

While illustrated in FIG. 29D as round in cross section, one or both ofthe first and second lumens may have other shapes. For example, FIG. 29Eillustrates a cross section of an alternate member 2906′ having a roundfirst lumen 2918′ and a second lumen 2920′ that is rectangular orotherwise elongate in cross section. The rectangular cross section lumen2920′, when occupied by a stiffening member of matching shape (e.g., anitinol wire or band of rectangular cross section), may reducerotational deflection (as well as other forms of deflection) of theelongate members 2906 during deployment. For example, because of thelesser moment about the minor dimension 2920 a′ compared to the majordimension 2920 b′, the elongate members 2906′ may preferentially bendoutwardly during expansion, rather than laterally, e.g., towards anadjacent elongate member.

While FIGS. 29D and 29E illustrate the members 2906 as dual lumentubing, the elongate members 2906 may also be made with a single lumen,such as polymer or other flexible tubing. The polymer tubing, whileflexible enough to be deployed into a curved configuration, may also besufficiently stiff so as not to require a secondary stiffening member.Such tubing may be fabricated from high durometer polymers, such asnylons, polyetheretherketones (PEEK), polyimides, and the like.Optionally the tubing cross section may be non-circular in cross section(e.g. trapezoidal, rectangular) to facilitate the proper orientation ofbending during device expansion and also to increase lateral stabilityof the elements while in the expanded position. Additionally, the tubingmay include reinforcing elements (e.g., flat wire braid, not shown)within its wall to provide enhanced torsional and flexural stiffness.

In further alternatives, the elongate members 2906 may include otherfeatures providing pathways extending between the proximal and distalends 2906 a, 2906 b. For example, the elongate members may includegrooves or tracks (not shown), which may receive one or more sources ofradiation (also not shown), as described further below. The features mayinclude any other interlocking features that restrict movement of one ormore sources of radiation, e.g., to axial movement along the elongatemembers. Thus, as used herein, “pathway” may include a lumen, track,rail, or other feature on an elongate member configured for guiding oneor more radiation sources along the elongate member.

FIG. 29F illustrates a proximal side of the flange 2914 as it may beconfigured in one embodiment. The flange 2914 may include a series ofopenings 2922 and 2924 that provide access to the lumens 2918 and 2920of the members 2906. For example, the opening 2922 may be coupled to thelumen 2918 (see FIG. 29D) in a respective elongate member 2906 via arespective lumen (not shown) extending through the body member 2907,while the opening 2924 may be coupled to the lumen 2920. As a result, abrachytherapy device and stiffening member (not shown) may be insertedinto their respective lumens 2918 and 2920 either before or after theapparatus 2900 is implanted into a target location, as describedelsewhere herein. Optionally, the flange 2914 may further include alocking member or ring (not shown) that may secure one or both of thebrachytherapy devices and stiffening members relative to the flange2914.

While not illustrated, the flange 2914 may include indicia (such asalphanumeric symbols, e.g., consecutive numbers like a clock) toidentify the respective openings 2922/2924 around the circumference ofthe flange 2914. As a result, the physician/oncologist may know whichopening 2922 is to receive a particular brachytherapy device inaccordance with a desired dose plan, e.g., before or after introducingthe apparatus 2900 into a target location. For example, the dose planmay call for a low activity device (device no. “1”) to be placed in anarea that is proximate the patient's skin. The corresponding opening2922/2924 may include the same number (no. “1”), or otherwise identifyit as the correct opening 2922/2924 to receive the particular lowactivity device. Thus, with the apparatus 2900 properly oriented withina target location (e.g., with the low activity pathway of elongatemember “1” oriented towards the skin), the low activity device may beplaced along the low activity pathway, which may reduce the risk ofdamaging the skin. Correspondingly, higher activity brachytherapydevices may be placed in other specified openings in accordance with thedesired dose plan.

Dose planning may be accomplished with the aid of current imagingmethods (e.g., CT or ultrasound) and with commercially available doseplanning software for either HDR or LDR applications. The timing andgeneral scenario of the dose planning process is at the discretion ofthe clinical physicist/oncologist. However, one such scenario mayinclude placing the apparatus 2900 into the target tissue region andactivating the elongate members 2906 into a deployed configuration.Then, with the aid of imaging (e.g., CT), both the target tissue regionand the position of the elongate members 2906 may be delineated. A doseplan may then be developed and, if desired, modified as configurationadjustments are made to the apparatus 2900 and the elongate members2906.

When the dose plan is optimized, the characteristics of the radioactivesources (e.g., brachytherapy devices) are chosen (e.g., LDR seedactivity levels, HDR dwell positions, etc.), and prepared for placementinto the apparatus 2900 via the access openings 2922/2924. For example,during LDR brachytherapy, individual pods or other radiation sources maybe loaded into respective elongate members 2906 simultaneously orsequentially, thereby providing a three dimensional array of seeds orradiation sources that may remain in the target location for an extendedperiod of time. The seeds may be spaced apart on each pod or havedifferent radioactive intensities, according to the dose plan. Forexample, the seeds in different portions of the array may also havedifferent lengths and/or spacing along respective elongate members 2906such that the array is substantially asymmetrical, e.g., radially and/oraxially relative to a central axis of the apparatus 2900. Alternatively,during HDR brachytherapy, an individual radiation source may bepositioned sequentially along each pathway of the elongate members 2906for specified exposure times. Optionally, more than one HDR radiationsource may be directed along the pathways simultaneously.

While described herein as utilizing separate components, in otherembodiments of the apparatus 2900, the elongate members 2906 may extendfrom the distal hub 2909 proximally all the way to the flange 2914.Thus, the elongate members 2906 may define one or more lumens extendingfrom their respective distal ends 2906 a to the flange 2914. The lumensmay then receive a brachytherapy device (not shown) having its ownstiffening member incorporated therein, see, e.g., device 1202 describedelsewhere herein. Alternatively, the elongate members 2906 may alreadyinclude stiffening members, e.g., within the lumens 2920 or otherwisesecured along the elongate members 2906.

Optionally, the stiffening members may provide shielding, similar toother embodiments described elsewhere herein. For example, withgenerally spherical arrays or radioactive sources, a central region ofthe array tends to receive greater radioactive exposure than peripheralregions of the array. Shielding placed along inner regions of theelongate members 2906 may reduce overdosing in the central region. Forexample, FIGS. 32F and 32G show stiffening/attenuating members extendingalong inner regions of the elongate members 3106 for this purpose.

FIGS. 30A-30C illustrate a brachytherapy apparatus 3000 similar in manyrespects to the apparatus 2900 described above. The apparatus 3000differs however, in that it is designed to penetrate entirely through abody or tissue structure, e.g., through a breast (not shown). As aresult, a distal end of the apparatus 3000 is modified somewhat from theapparatus 2900 to accommodate this application.

FIG. 30A illustrates a side elevation view of the apparatus 3000. Likethe apparatus 2900, the apparatus 3000 includes radioactive and flexibleelongate members 3006 that are coupled at a proximal end 3006 a to abody member 3007 and, at a distal end 3006 b, to a hub 3009. A coremember 3010, having a button 3012 at one end and a sharp distal tip 3011at the other, may extend through the body member 3007 and the hub 3009.The sharp distal tip 3011 may permit penetration of tissue by theapparatus 3000 during implantation. Unlike the apparatus 2900, the coremember 3010 is not permanently fixed to the hub 3009. Rather, it mayslide relative to the hub 3009 and the body member 3007. Optionally, thecore member 3010, body member 3007, and/or hub 3009 may include one ormore connectors (not shown) for releasably securing the core member3010, e.g., during implantation, but allowing the core member 3010 to beremoved after implantation.

FIG. 30B illustrates a cross-sectional view of the apparatus 3000 in afirst collapsed configuration. As illustrated in this view, the elongatemembers 3006 include lumens 3018, 3020 (e.g., similar to lumens 2918 and2920 illustrated in FIG. 29D) that either extend through the body member3007, or that communicate with separate lumens 3022 and 3024 that extendthrough the body member 3007. As a result, brachytherapy devices, e.g.,device 102, 152, 402, 502, and 602 described above, may be threaded intothe elongate members 3006 either before or after implantation of theapparatus 3000.

FIG. 30C illustrates a cross-sectional view of the apparatus 3000 in thesecond expanded configuration. This configuration is achieved bydisplacing the hub 3009 and body member 3007 towards one another, e.g.,using an actuator, such as the button 3012 and flange 3014, or otherembodiments described herein.

In use, while in the collapsed configuration shown in FIG. 30B, theapparatus 3000 may be inserted into the body, e.g., breast or othertissue structure (not shown), until the elongate members 3006 aredisposed within a cavity or other target location (also not shown). Theapparatus 3000 may be inserted until the hub 3009 extends out theopposite (distal) side of the breast. The sharp tip 3011 of the coremember 3010 may be used to penetrate tissue on either side of the cavityduring implantation. Optionally, once the apparatus 3000 is passedentirely through the breast, the core member 3010 may be removed fromthe apparatus 3000, e.g., by pulling the core member 3010 out theproximal end of the apparatus 3000. At this point, the physician maygrasp the body member 3007 and the hub 3009 and push the two components3007, 3009 towards one another. As this occurs, the elongate members3006 expand radially outwardly towards the cavity walls, e.g., towardsthe expanded configuration illustrated in FIG. 30C.

When fully deployed, the body member 3007 and the hub 3009 may besecured to the body, e.g., to the skin, with tape, sutures, or the like.Alternatively, a locking member (not shown) may be inserted through thebody member 3007 and/or the hub 3009 that holds the two componentsrelative to one another (e.g., a long plastic threaded bolt with nut,not shown). In another alternative, movement of the body member 3007and/or hub 3009 may be limited, e.g., using ratchets, detents, and thelike (not shown) that may fix the body member 3007 and hub 3009 relativeto one another, but may be overcome to move the body member 3007 and/orhub 3009, as described elsewhere herein.

The brachytherapy devices (not shown) may be carried by the elongatemembers 3006 when the apparatus 3000 is introduced or the apparatus 3000may be introduced without the brachytherapy devices. If thebrachytherapy devices are not included in the apparatus 3000 atimplantation, a radiation oncologist or similarly trained clinician maythen insert the brachytherapy devices through the lumens 3022 or otherpathways along the elongate members 3006. Alternatively, automatedsystems may be provided for delivering one or more radiation sourcesalong the pathways. In other embodiments, the brachytherapy devices maybe preloaded into the apparatus 3000 before implantation, eitherremovably or permanently carried by the elongate members 3006.

FIGS. 31A-31F illustrate an in-situ actuatable brachytherapy treatmentapparatus 3100 in accordance with yet another embodiment. The apparatus3100 includes a series of radioactive and elongate flexible members3106, that are deployable from a first collapsed, e.g., straight,configuration (shown in FIG. 31A), to a second deployed e.g.,curvilinear, configuration (shown in FIG. 31B). In the collapsedconfiguration, the members 3106 may be collapsed against the apparatus3100 (e.g., are generally parallel to a central longitudinal axis of theapparatus 3100), e.g., to minimize size for implantation. However, inthe deployed configuration shown in FIG. 31B, at least a portion of theelongate members 3106 expand radially towards and/or into the outerwalls of a body cavity, e.g., a lumpectomy cavity (see, e.g., FIGS.32D-32G). As a result, the apparatus 3100 is generally fixed within thetissue surrounding the cavity.

In the illustrated embodiment, the elongate members 3106 may beconfigured in two distinct groups best viewed in FIG. 31B. The first orouter group includes elongate members identified by reference numeral3106 a and forms a football or watermelon-shaped boundary, as shown inFIG. 31B. The second or inner group includes elongate members identifiedby reference numeral 3106 b and defines a similar, but smaller,watermelon shape. In the illustrated embodiment, the outer groupincludes seven separate members 3106 a, while the inner group includesthree separate members 3106 b. However, other embodiments may vary thenumber of elongate members 3106 in either group. The elongate members3106 a and 3106 b may be referred to generically, or collectively, aselongate members 3106.

The elongate members 3106 may be attached at a first (e.g., proximal)end to a body member 3107. However, the elongate members 3106 a may beattached at their respective second (e.g., distal) ends to a distal hub3109, while the distal ends of the members 3106 b may be attached to aseparate floating hub 3108.

The apparatus 3100 may further include a core member 3110 that isattached to the distal hub 3109 and extends out the proximal side of thebody member 3107. The core member 3110 may be fixed to the distal hub3109, yet pass with clearance through openings in both the body member3107 and the floating hub 3108. As a result, the body member 3107 andthe floating hub 3108 may slide along the core member 3110, as furtherdescribed below. The core member 3110 may function as a tension member.As a result, it may be generally rigid or, alternatively, a tension-onlymember such as a cable or a suture.

Each of the elongate members 3106 may include a stiffening member, whichin the illustrated embodiments, is an elastic flat wire 3112. The wire3112 ensures that the elongate members 3106 expand and contract in thedesired orientation (e.g., without twisting). The wire 3112 may alsoprovide some integrity to the elongate members 3106, e.g., to ensurethat the elongate members 3106 may be forced outwardly into the cavitywalls with sufficient radial and lateral stability. While not wishing tobe bound to any particular material, the wires 3112 may, in oneembodiment, be made from tempered stainless steel or a shaped memoryalloy such as nitinol or the like. Such materials may permit theapparatus 3100 to invaginate the lumpectomy walls and/or remain in asubstantially secure geometry (see FIGS. 32D-32G), while also permittingcollapse of the apparatus 3100 to its pre-deployed configuration attherapy completion.

Individual tubes 3114 may be attached to respective flat wires 3112. Thetubes 3114 are operable to receive a brachytherapy device (not shown),as already described herein, e.g., devices similar to devices 102, 152,402, 502. Alternatively, the tubes 3114 may be made to receiveindividual radioactive sources, e.g., seeds 108 described elsewhereherein, and spacers, which may be loaded into the tubes 3114 during orbefore a treatment. Thus, the tubes 3114 may form the outer surface ofthe actual brachytherapy devices. The tubes 3114 may be made from mostany biocompatible material that is capable of retaining the radioactivesources or a pre-assembled brachytherapy device, e.g., fluoropolymers,such as fluorinated ethylene-propylene (FEP), nylon, and polyurethane.

FIG. 31C illustrates a side elevation view of the apparatus 3100, whileFIG. 31D illustrates an end view. These two views illustrate a variationof the body member 3107 that includes a flange 3111 formed thereon orattached thereto. This optional flange 3111 may be beneficial to thephysician during the implantation and/or removal process, by providing alocation to be gripped during positioning of the core member 3110.

FIG. 31E is a staggered longitudinal cross-sectional view of theapparatus 3100 in the collapsed configuration (by staggering thecross-section, this figure illustrates sections of two elongate members3106 a and two elongate members 3106 b that would not otherwise appearin a straight cross-section). In this view, the attachment of the coremember 3110 to the distal hub 3109 is clearly shown, as is the fixationof the flat wires 3112 with the distal hub 3109, the floating hub 3108,and the body member 3107.

FIG. 31E further illustrates a pocket 3116 formed within the distal hub3109. The pocket 3116 provides a stop surface that limits axial movementof the floating hub 3108 when the apparatus 3100 is in the deployedconfiguration. While illustrated as a pocket 3116, another embodimentcould be configured to have the floating hub 3108 merely contact a flatinside face of the distal hub 3109.

FIG. 31F is a staggered longitudinal cross-sectional view, similar toFIG. 31E, with the apparatus 3100 in the deployed configuration. Asshown in this view, the deployed configuration may be achieved byapplying a tensile force to the tail portion of the core member 3110while holding the body member 3107 in place. Applying such a tensileforce causes the distal hub 3109 to move towards the body member 3107.As this movement occurs, the elongate members 3106 a begin to bowoutwardly as illustrated. Once the floating hub 3108 contacts the pocket3116, the members 3106 b also begin to bow outwardly. Further tensioningof the core member 3110 may result in outward movement of both theelongate members 3106 a and 3106 b. By changing the axial position ofthe core member 3110 relative to the body member 3107, a variety ofdeployed diameters are possible. When the apparatus 3100 is deployed tothe desired diameter, a clamp or similar device (not shown) may becrimped around the core member 3110 immediately adjacent the body member3107 to prevent the core member 3110 from sliding relative to the bodymember 3107.

Other methods for securing the apparatus 3100 in the desired diametermay include a threaded nut and bolt assembly (not shown). For example,the body member 3107 may be split and externally threaded like aconventional machinist's collet (not shown). A nut (not shown) may bethreaded around the collet and tightened to hold the core member 3110,thereby holding the apparatus 3100 at the desired degree of expansion.Alternatively, the core member 3110 may include a series of closelyspaced holes or pockets (not shown) residing along the region where thecore member 3110 protrudes from body member 3107. A cotter pin or thelike (not shown) may be placed at the desired hole or pocket to hold theapparatus 3100 with the desired degree of expansion.

FIGS. 32A-32F illustrate a method for using the apparatus 3100 of FIGS.31A-31F. FIG. 32A illustrates a perspective view of a portion of a body(e.g., a breast 200) having a cavity (e.g., a lumpectomy cavity 202)formed therein by removal of cancerous tissue. The apparatus 3100 isshown inserted and in its collapsed position. The apparatus 3100 may beinserted via an existing incision, e.g., the incision used to performthe lumpectomy, or via a new incision created for delivering theapparatus 3100. FIGS. 32B and 32C illustrate a front and side view ofthe breast 200, respectively, with the collapsed apparatus 3100 shown inplace within the cavity 202.

Once the apparatus 3100 is in the desired position, the core member 3110may be pulled by the physician while the body member 3107 is heldagainst the breast incision. The length of the body member 3107 may besufficient to extend to the skin surface, regardless of the distancefrom the skin to the lumpectomy cavity 202. As the apparatus 3100deploys, it may tend to center itself within the cavity 202, e.g., asshown in FIGS. 32D-32F.

Alternatively, the apparatus 3100 may also move within the cavity duringexpansion of the apparatus 3100 due to varying amounts of penetration ofthe elongate members within the adjacent tissue. For example, as shownin FIG. 32H, the region adjacent the skin is less prone to penetrationby the elongate members 3106 than the tissue underlying the cavity 202.As shown in FIG. 32H, the elongate members 3106 may be sufficientlysmall such that at least some of the elongate members (e.g., elongatemembers 3106 _(i), 3106 _(ii)) may cut, tear, or otherwise penetratethrough tissue surrounding the cavity 202, thereby allowing radiation tobe delivered deeper into tissue than if there was no penetration of theelongate members 3106 into the adjacent tissue. This ability of theelongate members 316 to penetrate the tissue and, in some cases becircumferentially surrounded by adjacent tissue (e.g., as shown in FIG.32H), effectively provides an interstitial form of radionuclideplacement for the apparatus 3100.

FIG. 32D illustrates a perspective cross section of the breast 200 andcavity 202 with the apparatus 3100 shown in its full expandedconfiguration therein. As illustrated in this view, the elongate members3106 a may push beyond the walls of the cavity 202, resulting ininvagination of the tissue around the members 3106 a, e.g., portions ofwall tissue 3120 may flow, extrude, or extend inwardly between theelongate members 3106 a to substantially surround the elongate members.In one embodiment, the wall tissue 3120 may extend radially inwardlyabout 0.7 centimeter from the outermost elongate members 3106 a.However, actual invagination distances may vary based on severalvariables, including, for example, apparatus size and shape, cavity sizeand shape, and tissue properties. The elongate members 3106 b preferablyremain within the diameter defined by the innermost portions of theextruded wall tissue 3120. As can be appreciated from this view,invagination results in substantial fixation of the apparatus 3100relative to the surrounding tissue, and may distort the cavity 202 untilit generally conforms to the shape of the apparatus 3100.

In one embodiment, a vacuum system (not shown) may be coupled to theapparatus 3100. The vacuum system may apply a vacuum pressure to thecavity 202 to increase the degree of tissue invagination. Such a vacuummay be left active during all or part of the implantation period, or maybe disconnected immediately following treatment, e.g., for HDR therapy.

In still other embodiments, the elongate members 3106 a may beconductive or otherwise excitable, such as by radio frequency (RF). Suchactivation of the elongate members 3106 a after deployment may allow theelongate members 3106 a to cut into the cavity walls, and thereforepenetrate deeper into the surrounding tissue, which may further increasethe degree of invagination.

FIG. 32E illustrates a section view of the apparatus 3100 implanted andfully deployed. The inwardly extending wall tissue 3120 is clearlyvisible in this view. FIG. 32F illustrates a partial perspective sectionview of the cavity 202 with diagrammatic representations of the elongatemembers 3106 shown therein in their deployed configuration.

FIG. 32G illustrates a cross-sectional view of the cavity 202 with theapparatus 3100 in its deployed configuration (and with some structure ofthe apparatus 3100 removed for clarity). This view further illustratesexemplary dose clouds provided by the brachytherapy devices containedwithin the elongate members 3106. For example, each of the elongatemembers 3106 a may yield a dose cloud generally represented by circles3122, while each of the elongate members 3106 b may yield a simplifieddose cloud generally represented by circles 3124. The circles 3122 and3124 represent the effective two-dimensional cloud boundaries at aparticular cross section, i.e., the dose clouds may create two layers ofradiation, an outer layer around elongate members 3106 a and an innerlayer around elongate members 3106 b. The actual cloud produced by eachof the elongate members 3106 would be generally in the form of acurvilinear cylinder.

The three-dimensional cumulative effect of all the radiation sources ineach of the two layers of elongate members 3106 is a therapeutic dosecloud shell that extends over the volume of tissue that immediatelysurrounds the cavity 202. With proper dose mapping and dose selection,the three-dimensional dose cloud shell may typically expose an adequatemargin of tissue (e.g., one centimeter (1 cm) or more beyond the wall ofthe cavity 202) to the proper therapeutic dose. Because of theinterstitial nature of many of the radionuclide sources, a therapeuticdose may be delivered to the desired region of tissue with lower risk ofoverdose effects that might be obtained if all the radionuclide sourcesresided within or at the edge of the cavity 202 (e.g., as may occur witha balloon applicator or other intracavitary applicator).

In addition, unlike a balloon applicator, individual elongate members3106 may apply local discrete radial forces to surrounding tissue. Aballoon applicator has a continuous surface and, consequently, applies arelatively continuous radial force along its surface to the adjacentcavity surface. In contrast, because the elongate members 3106 areintermittently spaced with voids therebetween, each elongate member 3106may apply highly localized radial forces against the cavity surface,leading to invagination of tissue within the elongate members duringexpansion.

Turning to FIG. 32H, in some applications, one or more of the elongatemembers 3106 a _(iv), 3106 a _(v) may be located towards a relativelythin region of tissue adjacent the cavity 202, e.g., adjacent thepatient's skin. If pods or other radiation sources having uniformradiation intensities are introduced into each of the elongate members3106, there is a risk of overexposing or “burning” such thin tissueregions or the skin itself. For this reason, a dose plan may recommendintroducing a radiation source into the elongate members 3106 a _(iv),3106 a _(v) that has a relatively lower radiation intensity, or may evenhave one or more seeds “turned off” (i.e., by providing nonradioactivespacers between sources along at least a portion of one or both of theelongate members 3106 a _(iv), 3106 a _(v)).

Optionally, the dose plan may recommend delivering radiation to the thinregion from an inner layer of elongate members. For example, as shown inFIG. 32H, a single elongate member 3106 b _(i) may be provided that isdisposed between the elongate members 3106 a _(iv), 3106 a _(v) andcloser to the central axis of the core member 3110. A radiation sourcemay be introduced into the single elongate member 3106 b _(i) to deliverradiation past the elongate members 3106 a _(iv), 3106 a _(v) and intothe thin region of tissue. Thus, an inner layer of elongate members maybe provided to enhance delivering radiation locally according to adesired dose plan.

In the embodiment illustrated in FIGS. 32D-32H, the elongate members3106 a may be configured to be spaced about one centimeter (1 cm) fromeach other (when fully expanded) at their largest diameter (which may beup to about three centimeters (3 cm)). Moreover, the radioactivesources, e.g., seeds 108 as described elsewhere herein, may yield atherapeutic dose cloud (circle 3122 and 3124) about the wires ofapproximately one centimeter (1 cm). As a result, the apparatus 3100 mayprovide radiation to all, or substantially all, of the cavity wall andsurrounding tissue as represented by the circles 3122 and 3124 in FIG.32G. It is noted that the radiation sources used with the apparatus 3100may be low dose rate sources or, alternatively, high dose rate sources(such as Iridium or Ytterbium) that are delivered intermittently.

At the completion of brachytherapy treatment, the apparatus 3100 may bereturned to its collapsed configuration, and the apparatus 3100 removedfrom the breast 200 via the insertion incision.

FIGS. 33A-33G illustrate an intracavitary brachytherapy apparatus 3600in accordance with still yet another embodiment. The apparatus 3600 mayinclude a brachytherapy device 3602 having a therapy delivery portion3604 and external, e.g., tail, portions 3606.

As FIG. 33A illustrates, the therapy delivery portion 3604 may be formedby a deformable and elongate radioactive source, e.g., coil member 3608.The coil member 3608 may form a helical coil wound about an elongatecore member 3610. At least one end of the coil member 3608 (e.g., aproximal end) may be secured to an attachment member (e.g., a sleeve3612) that translates and/or rotates about the core member 3610. Thisconfiguration provides a low profile device that may be inserted into atarget region, e.g., lumpectomy cavity (not shown), via a relativelysmall incision. Once in place, however, the coil member 3608 may bedeployed to form a spiral pathway within the cavity as shown in FIG.33B. To deploy the device 3602, the sleeves 3612, which may extendoutside of the body after implantation, may be rotated about the coremember 3608 relative to one another. Relative rotation of the sleeves inone direction may cause the coil member 3608 to expand, i.e., move away,from the central core member 3610. Relative rotation of the sleeves 3612in the opposite direction may similarly cause the coil member 3608 tocontract around the core member 3610. The greater the expansilerotation, the more radial force may be exerted against the walls of thelumpectomy cavity. Greater force exerted against the walls of thelumpectomy cavity may result in a higher degree of invagination of thebreast tissue within the turns of the expanded coil member 3608.

In addition to rotational movement of the sleeves 3612, the sleeves mayalso translate axially relative to the core member 3610. Axialtranslation permits adjustment in length of the coil member 3608 when inits expanded configuration. Due to the ability to independently controlthe axial length and the diameter (and hence the expansile force againstthe cavity walls) of the coil member 3608, the apparatus 3600 may beutilized to treat a variety of sizes and shapes of lumpectomy cavities.

FIG. 33C is an enlarged view of the device 3602 when it is in apartially deployed position. FIG. 33D illustrates a cross section of theradioactive coil member 3608 taken normal to a central longitudinal axisof the coil member 3608 (e.g., taken along line D-D of FIG. 33C), whileFIG. 33E illustrates a cross section taken along the longitudinal axisof the coil member 3608. As can be seen in these views, in oneembodiment, the coil member 3608 may be an elongate tube having both afirst lumen 3614 and a second lumen 3616 that extend through theelongate tube between the sleeves 3612. The first lumen 3614 may house aradiation source, e.g., a series of radioactive seeds 108 that may beoffset from one another by optional spacers 110, as shown in FIG. 33E.The second lumen 3616 may contain a shaping and/or stiffening member,such as shaping wire 3618. The shaping wire 3618 may provide stiffnessand twisting resistance to the coil member 3608. In the illustratedembodiment, the shaping wire 3618 (and thus the second lumen 3616) isrectangular in cross section as shown in FIG. 33D. The rectangular shapeprovides desirable twisting resistance to the radioactive source 3608during deployment, e.g., it keeps the first lumen 3614 positionedoutwardly from the core member 3610 during deployment. However, othershapes are certainly possible without departing from the scope of theinvention.

The elongate tube that forms the coil member 3608 may be made fromvarious materials. For example, in one embodiment, the elongate tube ismade from extruded fluoropolymers or thermoplastics similar to thematerials described previously with respect to the member 2906.

The shaping wire 3618 may be made from most any material that canaccommodate the helical deployment without undue twisting or permanentdeformation. Exemplary materials for the shaping wire include shapedmemory alloys such as nitinol or the like.

In operation, the device 3602 may be inserted through a tissuestructure, e.g., breast 200, while the therapy delivery portion 3604,e.g., coil member 3608, is collapsed along the longitudinal axis of theapparatus 3600. The coil member 3608 may be inserted until it isgenerally centered in the lumpectomy cavity 3620 as shown in FIG. 33F.The device 3602 may enter through an existing incision (e.g., anincision made at the time of lumpectomy), or it may be placed via ahollow needle (not shown), e.g., as described elsewhere herein withrespect to other embodiments. Once the device 3602 is generally in placeas shown in FIG. 33F, the physician may manipulate (e.g., twist and/oraxially displace) the sleeves 3612 that now protrude from each side ofthe breast 200 to deploy the device 3602. FIG. 33G illustrates thedevice 3602 as it may be configured when fully deployed within cavity202. In an exemplary embodiment, the device 3602 may deploy such thatthe helical coil member 3608 pushes into the cavity walls as alreadydiscussed herein (see, e.g., FIGS. 32D-32G) to secure the apparatus 3600relative to the surrounding tissue.

To secure the device 3602 in place, the physician may fold the sleeves3612 that extend outside the body against the skin and secure them,e.g., with tape. Alternatively, locking members 3622 may be slid overthe ends of the core member 3610. Each locking member 3622 mayfrictionally engage its respective sleeve 3612 as well as the coremember 3610. By securing the sleeves 3612 relative to the core member3610, the device 3602 may be generally held in place for the course oftreatment.

While illustrated herein as utilizing proximal and/or distal sleevesthat may protrude outside the body during implantation, otherconfigurations may utilize sleeves that do not protrude. In this case, atool, e.g., hollow needle (not shown), may be inserted over the coremember to mechanically engage the sleeves and manipulate them as desired(from outside the body) relative to the core member.

FIG. 34 illustrates a single entry point variation of a brachytherapydevice 3702, similar to the device 3602 illustrated in the immediatelypreceding figures. In this embodiment, a brachytherapy device 3702 isprovided having a therapy delivery portion 3704 and a single tailportion 3706. The therapy delivery portion 3704 may be configured as acoil member 3708 substantially similar in construction to the coilmember 3608 described above (e.g., helically wound around a core member3710). The tail portion 3706 may also be formed by a sleeve 3712 similarin most respects to the sleeves 3612 described above. For example, thesleeve member 3712, which may be coupled to a proximal end of theradioactive source 3608, is operable to slide and/or rotate about thecore member 3710.

Unlike the device 3602, a distal end of the coil member 3708 may beattached directly to the core member 3710 at or near its distal end asshown in FIG. 34 such that manipulation of the portion of the coremember 3710 located outside the body will effect movement of the distalend of the radioactive source.

In operation, the device 3702 may be inserted, while in a collapsedconfiguration, through the body (e.g., the breast 200) such that thetherapy delivery portion 3704 (e.g., coil member 3708) is positionedwithin the lumpectomy cavity 3620. The device 3702 may enter through anexisting incision (e.g., made at the time of lumpectomy) or, it may beplaced via a needle (not shown), e.g., as described elsewhere hereinwith respect to other embodiments. Once the device 3702 is generally inplace as shown in FIG. 34, the physician may manipulate both the sleeve3712 and the core member 3710 that both protrude from a proximal side ofthe breast 200. That is, axial displacement of the sleeve 3712 towardsthe distal end of the core member 3710 while rotating the core member3710 (which is fixed to the distal end of the coil member 3708) maydeploy central portions of the coil member 3708 away from the coremember 3710 to an expanded configuration, as shown in FIG. 34 (onceagain, the device 3702 may expand into the tissue as already describedherein, see, e.g., FIGS. 32D-32F). The device 3702 may be secured in thedeployed configuration in the same manner as described above withrespect to the device 3602, e.g., with locking member 3622.

It should be understood that, just as apparatus 3100 includes an innerarray of elements 3106 b and an outer array of elements 3106 a, analternate embodiment of the apparatus 3600/3700 may also include aninner coiled member (not shown) along with outer coiled member 3608. Inboth cases, these dual layer devices allow for an additional radiallayer of radiation to be delivered. When combined with tissueinvagination, these dual layers provide multiple shells or layers ofdose clouds that may enshroud a significant thickness of breast tissuethat curves around a given lumpectomy cavity.

The apparatus described herein may permit brachytherapy devices (orother radiation sources), via a single point of entry, to deliverradiation to the tissue surrounding a cavity from a position within thecavity. Moreover, the intracavitary apparatus, methods, and systemsdescribed herein may permit substantial fixation of one or moreradioactive sources relative to the target tissue surrounding thecavity. The surrounding tissue may invaginate sufficiently around thedevices to ensure adequate fixation and/or sufficient depth ofpenetration of the desired radiation dose to the tissue adjacent thelumpectomy cavity throughout the implantation period. As a result, thedesired dose delivery to specific tissue may be achieved over the courseof brachytherapy treatment. Moreover, irradiation of unintendedtissue—due to movement of the device relative to the surroundingtissue—may be minimized.

The brachytherapy devices described herein may be implanted into (and/oraround) a tumor before surgical excision (neoadjuvantly), and thensubsequently removed before or at the time of surgery. Such treatmentsmay shrink or even destroy the tumor. In other embodiments, theapparatus and methods described herein may be used to deliverbrachytherapy after surgically removing tumor tissue to treatsurrounding tissue post-operatively (post-lumpectomy in breast). In someinstances, it is contemplated that brachytherapy apparatus and methodsdescribed and illustrated herein may supplement or reduce the need forconventional treatment options, e.g., tumor excision, full fieldexternal beam radiation therapy (EBRT), and chemotherapy. Alternatively,the methods described herein may be performed adjuvantly with these andother treatments, e.g., with chemotherapy, EBRT.

Treatment in accordance with the present invention may also avoid someof the disadvantages of HDR treatment, e.g., high activity, exposure ofunintended tissue, potentially bulky and protruding catheters, and/orthe need for numerous patient visits to receive treatment.Alternatively, the apparatus and methods described herein may be used toperform HDR treatment, e.g., by delivering one or more HDR radiationsources along pathways of the devices in accordance with known HDR doseplans. In a further alternative, a HDR radiation source (e.g., anIridium tipped afterloader cable from Varian Medical Systems, Inc., or asmall diameter x-ray source, such as those disclosed in U.S. PublicationNo. 2005/0061533A1, the disclosure of which is expressly incorporated byreference herein) may be advanced through any of the core membersdescribed herein, with the expandable devices opening a cavity tofacilitate delivering radiation more evenly to the tissue surroundingthe cavity. Optionally, the core member may shield the radiation sourceto direct radiation from the radiation source towards a desired portionof the surrounding tissue.

The brachytherapy devices described herein are also substantiallyflexible, in comparison to conventional HDR catheters, such that theymay be placed in either a straight or curvilinear (e.g., curved orspiral) fashion. Such flexibility may permit implantation of radiationsources (e.g., seeds) in configurations and locations that otherwise maybe considered inaccessible.

Apparatus and methods of the present invention may also potentiallyachieve desired dosage with relatively few catheters. For example, theapparatus and methods described herein potentially may obtain desireddose delivery levels with fewer catheters per target than is typicallyutilized with conventional HDR methods. Yet, the devices describedherein may still be implanted with the use of conventional imagingmethods (e.g. stereotactic X-ray, ultrasound, CT).

Apparatus and methods of the present invention may also provide otherbenefits to the patient. For example, potentially less skin damage anddiscomfort may result from smaller and more flexible catheterinsertions. Further, the small flexible tail portions, once in theirproper position, may be trimmed short, but may also be folded and tapedagainst the skin, unlike rigid HDR catheters. Thus, the patient may haveless discomfort over the course of treatment and potentially improvedpost-procedural cosmesis. Further, for example, apparatus and techniquesin accordance with the present invention may potentially result inreduced side effects as compared to other treatments, e.g., EBRT andchemo, and may require fewer hospital visits over the course of thetreatment regimen as compared to, for example, current HDRbrachytherapy.

Still further, the brachytherapy delivery systems described herein mayprovide a standardized dose of radiation based upon lesion size. As aresult, the need for extensive dose calculating and mapping systems maypotentially be reduced or eliminated with certain cancers (e.g.,breast).

The complete disclosure of the patents, patent documents, andpublications cited in the Background, the Detailed Description ofExemplary Embodiments, and elsewhere herein are incorporated byreference in their entirety as if each were individually incorporated.Additional information on brachytherapy apparatus and methods may befound in co-pending application Ser. Nos. 10/658,518, filed Sep. 9,2003, 60/731,879, filed Oct. 31, 2005, and 60/735,532, filed Nov. 10,2005, the entire disclosures of which are expressly incorporated byreference herein.

Exemplary embodiments of the present invention are described above.Those skilled in the art will recognize that many embodiments arepossible within the scope of the invention. Other variations,modifications, and combinations of the various components and methodsdescribed herein can certainly be made and still fall within the scopeof the invention. For example, any of the treatment devices describedherein may be combined with any of the delivery systems and methods alsodescribed herein. Thus, the invention is limited only by the followingclaims, and equivalents thereto.

1-13. (canceled)
 14. A brachytherapy treatment apparatus for treatingtissue surrounding a cavity within a body, comprising: an elongate bodycomprising a proximal end and a distal end configured for introductioninto a tract through tissue; a plurality of elongate members on thedistal end comprising pathways for receiving a source of radiationtherealong, the elongate members being movable from a collapsedconfiguration for introduction through a tissue tract to a targetlocation, and an expanded configuration for providing a threedimensional array of pathways at the target location; and a source ofradiation introduceable along the pathways for delivering radiation tothe target location, wherein the elongate members comprise first andsecond sets of elongate members, the first set of elongate membersspaced apart about a central axis of the elongate body such that thefirst set of elongate members generally define a first maximum diameterin the expanded configuration, the second set of elongate members spacedapart about the central axis such that the second set of elongatemembers generally define a second maximum diameter in the expandedconfiguration that is less than the first maximum diameter.
 15. Theapparatus of claim 14, wherein the second set of elongate members isangularly offset from the first set of elongate members about thecentral axis.
 16. The apparatus of claim 14, wherein the first set ofelongate members defines one of a football shape, a watermelon shape,and a generally spherical shape in the expanded configuration, andwherein the second set of elongate members defines a smaller shape thanthe first set of elongate members in the expanded configuration.
 17. Theapparatus of claim 14, wherein the elongate members comprise tubularmembers comprising lumens defining the pathways. 18-22. (canceled)
 23. Abrachytherapy treatment apparatus for treating tissue surrounding acavity within a body, comprising: an elongate body comprising a proximalend and a distal end sized for introduction into a tract through tissue;a plurality of tubular members on the distal end comprising lumens forreceiving a source of radiation therein, the tubular members beingmovable from a collapsed configuration for introduction through a tissuetract to a target location, and an expanded configuration for providinga three dimensional array of pathways at the target location; aplurality of openings communicating with respective lumens for insertingthe source of radiation into the lumens; and a hub coupled to proximalends of the tubular members, the hub being movable relative to theelongate body for moving the tubular members from the collapsedconfiguration to the expanded configuration, wherein the tubular memberscomprise first and second sets of tubular members, the first set oftubular members spaced apart about a central axis of the elongate bodysuch that the first set of tubular members generally define a firstmaximum diameter in the expanded configuration, the second set oftubular members spaced apart about the central axis such that the secondset of tubular members generally define a second maximum diameter in theexpanded configuration that is less than the first maximum diameter. 24.The apparatus of claim 23, wherein the second set of tubular members isangularly offset from the first set of tubular members about the centralaxis.
 25. The apparatus of claim 23, wherein the second set consists ofa single tubular member.
 26. The apparatus of claim 23, wherein atubular member of the second set of tubular members is disposed betweentwo adjacent tubular members in the first set of tubular members andcloser to the central axis in the expanded configuration.
 27. Theapparatus of claim 26, wherein at least one of the two adjacent tubularmembers in the first set of tubular members has a lower radioactiveintensity than the tubular member of the second set of tubular membersdisposed between the two adjacent tubular members.
 28. The apparatus ofclaim 26, wherein at least one of the two adjacent tubular members inthe first set of tubular members has one or more portions with noradiation source. 29-62. (canceled)
 63. A method for brachytherapytreatment of tissue within a body, comprising: creating a tract throughtissue to a target location adjacent to a cavity; advancing an elongatebody carrying a plurality of elongate members through the tract into thetarget location with the elongate members in a collapsed configuration;directing the elongate members to an expanded configuration at thetarget location to position the elongate members in a multiple layer,three dimensional array extending away from a central axis such that theelongate members exert respective local discrete radial forces intotissue surrounding the cavity; and delivering one or more sources ofradiation along elongate members of the multiple layer, threedimensional array to the target location to treat tissue at the targetlocation, the multiple layer, three dimensional array providing multiplelayers of radiation when the radiation is introduced into the elongatemembers.
 64. The method of claim 63, wherein the local discrete radialforces are sufficient to cause penetration of one or more of theelongate members into the tissue surrounding the cavity.
 65. The methodof claim 63, wherein the local radial forces of respective elongatemembers vary from one another.
 66. A brachytherapy device comprising: anexpandable outer cage; an expandable inner cage positioned within theouter cage and configured to receive radioactive material at itsperimeter; a movable actuator configured to cause the outer and innercages to expand simultaneously in response to movement of the actuatorbetween certain positions while maintaining a substantially constant andnon-zero separation distance between the outer and inner cages; a handlein which the movable actuator moves; and a rod running through the outerand inner cages that is attached to the handle at a distal end.
 67. Thebrachytherapy device of claim 66 wherein the movable actuator isconfigured to cause the outer cage to expand but not the inner cageduring movement of the actuator between certain other positions.
 68. Thebrachytherapy device of claim 66 wherein the movable actuator isconfigured to cause the outer and inner cages to expand in a directionperpendicular to the movement of the actuator.
 69. The brachytherapydevice of claim 66 further comprising a ring that is rotatable about anaxis and that is configured to cause the movable actuator to traversethe axis when the ring is rotated.
 70. The brachytherapy device of claim69 wherein the movable actuator and the rotatable ring have threads thatmesh.
 71. The brachytherapy device of claim 66 wherein the outer andinner cages each include a plurality of tubes, wherein each of the tubesand the rod have a proximal end, and wherein the proximal end of all ofthe tubes and the rod are affixed to one another.
 72. The brachytherapydevice of claim 71 wherein each of the tubes has a distal end andwherein the actuator is configured to engage the distal ends of thetubes.
 73. The brachytherapy device of claim 72 wherein the outer andinner cages are configured to collapse into a rod-like shape when thedistal ends of the tubes are not engaged by the actuator.
 74. Thebrachytherapy device of claim 66 wherein the actuator is configured toapply longitudinal compressive force to the distal ends of the tubes.75. The brachytherapy device of claim 66 wherein the inner cage iscomprised of hollow tubes, each of which are configured to receiveradioactive material at different locations therein.
 76. A brachytherapydevice comprising: an expandable outer cage; an expandable inner cagepositioned within the outer cage and configured to receive radioactivematerial at its perimeter; and a rotatable actuation mechanismconfigured to cause the outer and inner cages to expand and to be spacedapart in response to rotations of the rotatable actuator between certainpositions.
 77. The brachytherapy device of claim 76 wherein theexpandable inner cage is comprised of hollow tubes, each configured toreceive radioactive material at different locations therein.
 78. Thebrachytherapy device of claim 76 wherein the outer and inner cages areconfigured to collapse into a rod-like shape when not expanded byrotation of the rotatable actuation mechanism.
 79. The brachytherapydevice of claim 76 wherein rotation of the rotatable actuation mechanismbetween certain other positions causes the outer cage to expand but notthe inner cage.
 80. The brachytherapy device of claim 76 wherein therotatable actuation mechanism includes a ring and an actuator.
 81. Thebrachytherapy apparatus of claim 14, wherein at least some of thepathways of the first set of elongate members comprise nonradioactivespacers.